CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report

Medtronic Venous Cannulae: a) DLP¿. Malleable Single Stage recalled

Medtronic Perfusion Systems is recalling Medtronic Venous Cannulae: a) DLP¿. Malleable Single Stage Venous Cannula. The recall was initiated on 19 Mar 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Model Number 68120, GTIN 20613994879435, Lot Numbers: 2023041436; b) Model Number 68124, GTIN 00613994879417, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 00681490466349, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 20613994879411, Lot Numbers: 2023041441, 2023041448, 202306C008; c) Model Number 68128, GTIN 00613994879394, Lot Numbers: 2023041040; c) Model Number 68128, GTIN 00681490466363, Lot Numbers: 2023041388; c) Model Number 68128, GTIN 20613994879398, Lot Numbers: 2023041040, 2023041388, 202306C010, 202306C011; d) Model Number 68130, GTIN 20613994879381, Lot Numbers: 2023041390, 202308C131; e) Model Number 68134, GTIN 20613994879367, Lot Numbers: 2023041431; f) Model Number 67312, GTIN 00613994879325, Lot Numbers: 2023041423; f) Model Number 67312, GTIN 00673978184180, Lot Numbers: 2023040074; f) Model Number 67312, GTIN 20613994879329, Lot Numbers: 2023040073, 2023040074, 2023041423; g) Model Number 67316, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; g) Model Number 67316, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; h) Model Number 67516, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; h) Model Number 67516, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; i) Model Number 66118, GTIN 00613994878526, Lot Numbers: 2023041014; i) Model Number 66118, GTIN 20613994878520, Lot Numbers: 2023041014, 2023041015; j) Model Number 67318, GTIN 00613994879295, Lot Numbers: 2023040077; j) Model Number 67318, GTIN 00673978184241, Lot Numbers: 2023040077, 2023041391; j) Model Number 67318, GTIN 20613994879299, Lot Numbers: 2023040077, 2023041391, 202305C256; k) Model Number 67320, GTIN 00613994879288, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 00673978184258, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 20613994879282, Lot Numbers: 2023031377, 202307C051; l) Model Number 69320, GTIN 00613994879233, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 00673978184609, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 20613994879237, Lots Numbers: 2023041422, 2023041438, 202306C014, 202306C015; m) Model Number 67520, GTIN 00613994878359, Lot Numbers: 2023040082; m) Model Number 67520, GTIN 20613994878353, Lot Numbers: 2023040082; n) Model Number 66122, GTIN 20613994878544, Lot Numbers: 2023041016; o) Model Number 67522, GTIN 00613994878366, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 00673978184326, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 20613994878360, Lot Numbers: 2023040083, 2023040565, 202307C050; p) Model Number 67524, GTIN 00673978184333, Lot Numbers: 2023040084; p) Model Number 67524, GTIN 20613994878377, Lot Numbers: 2023040084, 2023040566, 202305C257; q) Model Number 67526, GTIN 00673978165585, Lot Numbers: 2023040569; q) Model Number 67526, GTIN 20613994878384, Lot Numbers: 2023040569, 202308C082; r) Model Number 66128, GTIN 00613994878571, Lot Numbers: 2023041020; r) Model Number 66128, GTIN 20613994878575, Lot Numbers: 2023041020, 202305C177; s) Model Number 39628, GTIN t) Model Number 67528, GTIN 20613994878391, Lot Numbers: 2023041036; u) Model Number 66130, GTIN 00613994878588, Lot Numbers: 2023040555, 202305C217; u) Model Number 66130, GTIN 20613994878582, Lot Numbers: 2023040555, 2023041414, 202305C217, 202305C218; v) Model Number 69331, GTIN 20613994879183, Lot Numbers: 2023041444, 202307C012; w) Model Number 66132, GTIN 00613994878601, Lot Numbers: 2023041428; w) Model Number 66132, GTIN 20613994878605, Lot Numbers: 2023041412, 2023041428, 202305C227; x) Model Number 67534, GTIN 20613994878421, Lot Numbers: 2023031249, 202308C079; y) Model Number 66236, GTIN 20613994878643, Lot Numbers: 2023041398, 202305C222; z) Model Number 91228, GTIN 20643169463015, Lot Numbers: 2023041070; aa) Model Number 91229C, GTIN 20643169463060, Lot Numbers: 2023041071; bb) Model Number 91263, GTIN 00673978187761, Lot Numbers: 2023041095; bb) Model Number 91263, GTIN 20613994887454, Lot Numbers: 2023041095, 202306C105; cc) Model Number 91240C, GTIN 00613994887306, Lot Numbers: 2023041082, 2023041083, 2023041084; cc) Model Number 91240C, GTIN 20613994887300, Lot Numbers: 2023041079, 2023041081, 2023041082, 2023041083, 2023041084, 2023041087, 2023041088, 202306C074, 202306C075, 202306C076, 202306C077; dd) Model Number 91263C, GTIN 20613994887447, Lot Numbers: 2023040116, 2023041097, 202306C103; ee) Model Number 91246, GTIN 00613994887535, Lot Numbers: 2023041089; ee) Model Number 91246, GTIN 20613994887539, Lot Numbers: 2023041089, 202306C101; ff) Model Number 91246C, GTIN 00613994887528, Lot Numbers: 2023041090; ff) Model Number 91246C, GTIN 20613994887522, Lot Numbers: 2023041090, 202306C123; gg) Model Number 91236C, GTIN 00613994887344, Lot Numbers: 2023041072; gg) Model Number 91236C, GTIN 20613994887348, Lot Numbers: 2023041072, 202306C065; hh) Model Number 91251, GTIN 00613994887498, Lot Numbers: 2023041092, 2023041094; hh) Model Number 91251, GTIN 20613994887492, Lot Numbers: 2023041092, 2023041094; ii) Model Number 91251C, GTIN 00613994887481, Lot Numbers: 2023040618, 202306C102; ii) Model Number 91251C, GTIN 20613994887485, Lot Numbers: 2023040617, 2023040618, 202306C102; jj) Model Number 93438, GTIN 00673978188201, Lot Numbers: 2023040626; jj) Model Number 93438, GTIN 20613994887034, Lot Numbers: 2023040626; kk) Model Number 93448C, GTIN 20613994887256, Lot Numbers: 2023040627

Quantity recalled17221 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1805-2024
FDA event ID: 94274
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Classification: Class II
Status: Ongoing
Recall initiated: 19 Mar 2024
FDA classified: 10 May 2024
Reported: 22 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

19 Mar 2024	Recall initiated by company
10 May 2024	Classified by FDA	+52 days
22 May 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for unsealed sterile packing.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP¿ 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP¿ 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP¿ 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP¿ 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP¿ 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP¿ 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP¿ 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP¿ 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP¿ 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP¿ 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP¿ 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP¿ 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP¿ 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP¿ 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP¿ 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2¿ 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2¿ 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2¿ 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2¿ 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2¿ 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2¿ 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2¿ 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Potential for unsealed sterile packing.

Which lots are affected?

a) Model Number 68120, GTIN 20613994879435, Lot Numbers: 2023041436; b) Model Number 68124, GTIN 00613994879417, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 00681490466349, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 20613994879411, Lot Numbers: 2023041441, 2023041448, 202306C008; c) Model Number 68128, GTIN 00613994879394, Lot Numbers: 2023041040; c) Model Number 68128, GTIN 00681490466363, Lot Numbers: 2023041388; c) Model Number 68128, GTIN 20613994879398, Lot Numbers: 2023041040, 2023041388, 202306C010, 202306C011; d) Model Number 68130, GTIN 20613994879381, Lot Numbers: 2023041390, 202308C131; e) Model Number 68134, GTIN 20613994879367, Lot Numbers: 2023041431; f) Model Number 67312, GTIN 00613994879325, Lot Numbers: 2023041423; f) Model Number 67312, GTIN 00673978184180, Lot Numbers: 2023040074; f) Model Number 67312, GTIN 20613994879329, Lot Numbers: 2023040073, 2023040074, 2023041423; g) Model Number 67316, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; g) Model Number 67316, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; h) Model Number 67516, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; h) Model Number 67516, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; i) Model Number 66118, GTIN 00613994878526, Lot Numbers: 2023041014; i) Model Number 66118, GTIN 20613994878520, Lot Numbers: 2023041014, 2023041015; j) Model Number 67318, GTIN 00613994879295, Lot Numbers: 2023040077; j) Model Number 67318, GTIN 00673978184241, Lot Numbers: 2023040077, 2023041391; j) Model Number 67318, GTIN 20613994879299, Lot Numbers: 2023040077, 2023041391, 202305C256; k) Model Number 67320, GTIN 00613994879288, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 00673978184258, Lot Numbers: 2023031377; k) Model Number 67320, GTIN 20613994879282, Lot Numbers: 2023031377, 202307C051; l) Model Number 69320, GTIN 00613994879233, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 00673978184609, Lot Numbers: 2023041422; l) Model Number 69320, GTIN 20613994879237, Lots Numbers: 2023041422, 2023041438, 202306C014, 202306C015; m) Model Number 67520, GTIN 00613994878359, Lot Numbers: 2023040082; m) Model Number 67520, GTIN 20613994878353, Lot Numbers: 2023040082; n) Model Number 66122, GTIN 20613994878544, Lot Numbers: 2023041016; o) Model Number 67522, GTIN 00613994878366, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 00673978184326, Lot Numbers: 2023040083, 2023040565; o) Model Number 67522, GTIN 20613994878360, Lot Numbers: 2023040083, 2023040565, 202307C050; p) Model Number 67524, GTIN 00673978184333, Lot Numbers: 2023040084; p) Model Number 67524, GTIN 20613994878377, Lot Numbers: 2023040084, 2023040566, 202305C257; q) Model Number 67526, GTIN 00673978165585, Lot Numbers: 2023040569; q) Model Number 67526, GTIN 20613994878384, Lot Numbers: 2023040569, 202308C082; r) Model Number 66128, GTIN 00613994878571, Lot Numbers: 2023041020; r) Model Number 66128, GTIN 20613994878575, Lot Numbers: 2023041020, 202305C177; s) Model Number 39628, GTIN t) Model Number 67528, GTIN 20613994878391, Lot Numbers: 2023041036; u) Model Number 66130, GTIN 00613994878588, Lot Numbers: 2023040555, 202305C217; u) Model Number 66130, GTIN 20613994878582, Lot Numbers: 2023040555, 2023041414, 202305C217, 202305C218; v) Model Number 69331, GTIN 20613994879183, Lot Numbers: 2023041444, 202307C012; w) Model Number 66132, GTIN 00613994878601, Lot Numbers: 2023041428; w) Model Number 66132, GTIN 20613994878605, Lot Numbers: 2023041412, 2023041428, 202305C227; x) Model Number 67534, GTIN 20613994878421, Lot Numbers: 2023031249, 202308C079; y) Model Number 66236, GTIN 20613994878643, Lot Numbers: 2023041398, 202305C222; z) Model Number 91228, GTIN 20643169463015, Lot Numbers: 2023041070; aa) Model Number 91229C, GTIN 20643169463060, Lot Numbers: 2023041071; bb) Model Number 91263, GTIN 00673978187761, Lot Numbers: 2023041095; bb) Model Number 91263, GTIN 20613994887454, Lot Numbers: 2023041095, 202306C105; cc) Model Number 91240C, GTIN 00613994887306, Lot Numbers: 2023041082, 2023041083, 2023041084; cc) Model Number 91240C, GTIN 20613994887300, Lot Numbers: 2023041079, 2023041081, 2023041082, 2023041083, 2023041084, 2023041087, 2023041088, 202306C074, 202306C075, 202306C076, 202306C077; dd) Model Number 91263C, GTIN 20613994887447, Lot Numbers: 2023040116, 2023041097, 202306C103; ee) Model Number 91246, GTIN 00613994887535, Lot Numbers: 2023041089; ee) Model Number 91246, GTIN 20613994887539, Lot Numbers: 2023041089, 202306C101; ff) Model Number 91246C, GTIN 00613994887528, Lot Numbers: 2023041090; ff) Model Number 91246C, GTIN 20613994887522, Lot Numbers: 2023041090, 202306C123; gg) Model Number 91236C, GTIN 00613994887344, Lot Numbers: 2023041072; gg) Model Number 91236C, GTIN 20613994887348, Lot Numbers: 2023041072, 202306C065; hh) Model Number 91251, GTIN 00613994887498, Lot Numbers: 2023041092, 2023041094; hh) Model Number 91251, GTIN 20613994887492, Lot Numbers: 2023041092, 2023041094; ii) Model Number 91251C, GTIN 00613994887481, Lot Numbers: 2023040618, 202306C102; ii) Model Number 91251C, GTIN 20613994887485, Lot Numbers: 2023040617, 2023040618, 202306C102; jj) Model Number 93438, GTIN 00673978188201, Lot Numbers: 2023040626; jj) Model Number 93438, GTIN 20613994887034, Lot Numbers: 2023040626; kk) Model Number 93448C, GTIN 20613994887256, Lot Numbers: 2023040627

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 94274

This product is part of a recall event; the main page for the event is Medtronic Disposable Pressure Display Sets: a) DLP¿ recalled.

Reported	Class	Recall	Company	Reason	Where
22 May 2024	CLASS II	Medtronic Disposable Pressure Display Sets: a) DLP¿ recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Vessel Cannulae: a) DLP¿ Vessel Cannula Blunt Tip recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Intracoronary Shunts: a) ClearView¿ Intracoronary Shunt recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic DLP Coronary Ostial Cannulae recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic I.M.A recalled by Medtronic Perfusion Systems	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Tourniquet Sets: a) DLP¿ Tourniquet Kit recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Clearview Blower/Mister recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Aortic Root Cannulae and Cardioplegia Needles recalled	Medtronic Perfusion Systems	Sterility	MN
22 May 2024	CLASS II	Medtronic Arterial Cannulae packaged as recalled	Medtronic Perfusion Systems	Sterility	MN

More recalls from Medtronic Perfusion Systems

All 116

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Device	CLASS II	Eopa Elongated One-Piece Arterial Cannula Blunt recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA Elongated One-Piece Arterial Cannula DIL TIP recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Eopa Elongated One-Piece Arterial Cannula Blunt recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA 3D Arterial Cannula DIL TIP, intended for use recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA 3D Arterial Cannula, intended for use recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide