FDAFDA · Food and drugs·Recall number Z-1508-2013
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.
Published June 12, 2013 · Recall initiated: April 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cordis Corporation
- Distributor
- 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
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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