CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report
Flexstent Femoropopliteal Self-Expanding Stent System recalled by Cordis
Cordis is recalling Flexstent Femoropopliteal Self-Expanding Stent System, distributed nationwide in the US. The recall was initiated on 23 Apr 2013 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-1508-2013
- FDA event ID
- 65182
- Recalling firm
- Cordis, Miami Lakes, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Apr 2013
- FDA classified
- 6 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 23 Apr 2013 | Recall initiated by company | |
| 6 Jun 2013 | Classified by FDA | +44 days |
| 12 Jun 2013 | 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
Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Product as listed by the FDA
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
Nationwide ArizonaCaliforniaConnecticutFloridaGeorgiaIowaIllinoisLouisianaMarylandMichiganMississippiNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaRhode IslandSouth CarolinaTexasWashington
Questions about this recall
Why was it recalled?
Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Which lots are affected?
28 Catalog Numbers CAC-50030-V2, CAC-60030-V2, CAC-70030-V2, CAC-80030-V2, CAC-50040-V2, CAC-60040-V2, CAC-70040-V2, CAC-80040-V2, CAC-50060-V2, CAC-60060-V2, CAC-70060-V2, CAC-80060-V2, CAC-50080-V2, CAC-60080-V2, CAC-70080-V2, CAC-80080-V2, CAC-50100-V2, CAC-60100-V2, CAC-70100-V2, CAC-80100-V2, CAC-50120-V2, CAC-60120-V2, CAC-70120-V2, CAC-80120-V2, CAC-50150-V2, CAC-60150-V2, CAC-70150-V2, CAC-80150-V2
Where was it sold?
Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
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
4 other products · FDA event 65182This product is part of a recall event; the main page for the event is Flexstent Biliary Self-Expanding Stent System recalled by Cordis.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Flexstent Biliary Self-Expanding Stent System recalled by Cordis | Cordis | Other | Nationwide | |
| CLASS II | Flexstent Femoropopliteal Self-Expanding Stent System recalled by Cordis | Cordis | Other | Nationwide | |
| CLASS II | Flexstent Femoropopliteal Self-Expanding Stent System recalled by Cordis | Cordis | Other | Nationwide | |
| CLASS II | Flexstent Biliary Self-Expanding Stent System recalled by Cordis | Cordis | Other | Nationwide |
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 |