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.
This recall has been terminated (originally issued June 6, 2013).
- Company
- Cordis Corporation
- Recall Initiated
- April 23, 2013
- Posted
- June 6, 2013
- Terminated
- June 27, 2014
- Recall Number
- Z-1510-2013
- Quantity
- 250 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
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.
Distribution
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
Lot / Code Info
32 Catalog Numbers FLX-50030-V1, FLX-60030-V1, FLX-70030-V1, FLX-80030-V1, FLX-50040-V1, FLX-60040-V1, FLX-70040-V1, FLX-80040-V1, FLX-50060-V1, FLX-60060-V1, FLX-70060-V1, FLX-80060-V1, FLX-50080-V1, FLX-60080-V1, FLX-70080-V1, FLX-80080-V1, FLX-50100-V1, FLX-60100-V1, FLX-70100-V1, FLX-80100-V1, FLX-50120-V1, FLX-60120-V1, FLX-70120-V1, FLX-80120-V1, FLX-50150-V1, FLX-60150-V1, FLX-70150-V1, FLX-80150-V1, FLX-50200-V1, FLX-60200-V1, FLX-70200-V1, FLX-80200-V1
Root Cause
Package design/selection
Action Taken
Cordis sent an Urgent Medical Device Correction and Potential Removal letter dated April 24, 2013 e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected products to prevent further use of the affected product, until inspected. Use only product identified with a blue dot next to the lot number on the carton face label, carton end label, and outer pouch label, or product with upgraded sterile barrier system (not yet available, as of the date of this letter), review, complete, sign and return the enclosed Acknowledgement Form and maintain a copy of this notice with the affected product. For questions related to the issue, please contact our FSS/Cordis representative, or please contact Cordis Direct at (800) 781-0282, Monday through Friday from 9:00 AM to 5:00 PM EDT.