CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report

Medtronic 6F Launcher Guide Catheter JR recalled by Medtronic Vascular

Medtronic Vascular is recalling Medtronic 6F Launcher Guide Catheter JR 4.0, distributed nationwide in the US. The recall was initiated on 15 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 220754416, 220754417

Quantity recalled9 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-1246-2021
FDA event ID: 87284
Recalling firm: Medtronic Vascular, Danvers, MA
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2021
FDA classified: 11 Mar 2021
Reported: 17 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

15 Jan 2021	Recall initiated by company
11 Mar 2021	Classified by FDA	+55 days
17 Mar 2021	Published in enforcement report	+6 days

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

Reason for recall

Sterility may be compromised due to an unsealed pouch

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 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Sterility may be compromised due to an unsealed pouch

Which lots are affected?

Lot Code: 220754416, 220754417

Where was it sold?

Nationwide

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

3 other products · FDA event 87284

This product is part of a recall event; the main page for the event is Medtronic 6F Launcher Guide Catheter EBU recalled by Medtronic Vascular.

Reported	Class	Recall	Company	Reason	Where
17 Mar 2021	CLASS II	Medtronic 6F Launcher Guide Catheter EBU recalled by Medtronic Vascular	Medtronic Vascular	Sterility	Nationwide
17 Mar 2021	CLASS II	Medtronic 6F Launcher Guide Catheter EBU recalled by Medtronic Vascular	Medtronic Vascular	Sterility	Nationwide
17 Mar 2021	CLASS II	Medtronic 6F Launcher Guide Catheter 100 cmJL recalled	Medtronic Vascular	Sterility	Nationwide

More recalls from Medtronic Vascular

All 227

Reported	Class	Recall	Company	Reason	Where
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1 Dec 2021Device	CLASS II	Endurant IIs Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant II Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	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