Z-1511-2013 Class II Terminated
FDA device recall Z-1511-2013 was initiated by Cordis Corporation on Apr 23, 2013 and is designated Class II. 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. The recall status is terminated (terminated Jun 27, 2014). Affected quantity: 310 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2013
- Initiation Date
- Apr 23, 2013
- Termination Date
- Jun 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 310 units
Product Description
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.
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 Pattern
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
Code Information
32 Catalog Numbers FLX-50030-V2, FLX-60030-V2, FLX-70030-V2, FLX-80030-V2, FLX-50040-V2, FLX-60040-V2, FLX-70040-V2, FLX-80040-V2, FLX-50060-V2, FLX-60060-V2, FLX-70060-V2, FLX-80060-V2, FLX-50080-V2, FLX-60080-V2, FLX-70080-V2, FLX-80080-V2, FLX-50100-V2, FLX-60100-V2, FLX-70100-V2, FLX-80100-V2, FLX-50120-V2, FLX-60120-V2, FLX-70120-V2, FLX-80120-V2, FLX-50150-V2, FLX-60150-V2, FLX-70150-V2, FLX-80150-V2, FLX-50200-V2, FLX-60200-V2, FLX-70200-V2, FLX-80200-V2
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1511-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026