CLASS II Device recall · Reported 17 Jan 2018 · FDA Enforcement Report

S.M.A.R.T. Flex Biliary Stent System recalled by Cordis

Cordis is recalling S.M.A.R.T. Flex Biliary Stent System, distributed nationwide in the US. The recall was initiated on 15 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352, 20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 20705032066263 SF09060MB 41003 and 41359, 20705032065938 SF09060SB 41122, 20705032066096 SF09080MB 40998, 20705032066072 SF09080SB 41004 and 41202, 20705032065778 SF09100SB 40996 and 41124, 20705032065570 SF10040SB 41322, 20705032065945 SF10060SB 41002, 20705032066089 SF10080SB 41323, and 20705032066317 SF10100MB 41058.

Quantity recalled511

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-0324-2018
FDA event ID: 78674
Recalling firm: Cordis, Miami Lakes, FL
Classification: Class II
Status: Terminated
Recall initiated: 15 Nov 2017
FDA classified: 9 Jan 2018
Reported: 17 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

15 Nov 2017	Recall initiated by company
9 Jan 2018	Classified by FDA	+55 days
17 Jan 2018	Published in enforcement report	+8 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 cracked luer hubs

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.

Nationwide Alabama Arkansas Arizona California Colorado District of Columbia Florida Georgia Iowa Illinois Indiana Louisiana Massachusetts Michigan Mississippi North Carolina New Jersey Nevada New York Ohio

Questions about this recall

Why was it recalled?

Potential for cracked luer hubs

Which lots are affected?

GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352, 20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 20705032066263 SF09060MB 41003 and 41359, 20705032065938 SF09060SB 41122, 20705032066096 SF09080MB 40998, 20705032066072 SF09080SB 41004 and 41202, 20705032065778 SF09100SB 40996 and 41124, 20705032065570 SF10040SB 41322, 20705032065945 SF10060SB 41002, 20705032066089 SF10080SB 41323, and 20705032066317 SF10100MB 41058.

Where was it sold?

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.

More recalls from Cordis

All 39

Reported	Class	Recall	Company	Reason	Where
24 Nov 2021Device	CLASS II	Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled	Cordis	Other	7 states
24 Nov 2021Device	CLASS II	Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled	Cordis	Other	7 states
24 Nov 2021Device	CLASS II	Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled	Cordis	Other	7 states
24 Nov 2021Device	CLASS II	Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled	Cordis	Other	7 states
24 Nov 2021Device	CLASS II	Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled	Cordis	Other	7 states

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