CLASS II ONGOING Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled
Cordis is recalling Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the, distributed in 7 states. The recall was initiated on 1 Oct 2021 and the FDA has classified it as Class II.
Check your package
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-0217-2022
- FDA event ID
- 88821
- Recalling firm
- Cordis, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Oct 2021
- FDA classified
- 12 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 1 Oct 2021 | Recall initiated by company | |
| 12 Nov 2021 | Classified by FDA | +42 days |
| 24 Nov 2021 | 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
There is a potential for distal tip dislodgement or separation.
Product as listed by the FDA
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Where it was distributed
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
Questions about this recall
Is Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the recalled?
Yes. Cordis recalled Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the on 1 Oct 2021. The recall is Class II and its status is Ongoing. Recall number Z-0217-2022.
Why was it recalled?
There is a potential for distal tip dislodgement or separation.
Which lots are affected?
Product Code: SF06120MB; Lot No. 266401
Where was it sold?
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
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 21 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |