FLEXSTENT Femoropopliteal Self-Expanding Stent System. recall
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for…
Why was FLEXSTENT Femoropopliteal Self-Expanding Stent System. 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for…
- Recalling firm
- Cordis Corporation
- Quantity
- 250 units
- 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
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)