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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

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.
Recall Number Z-1511-2013
Classification Class II
Code Info 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
Product Distributed Qty 310
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.

Event Detail

Event Id 65182
Product Type Devices
Status Ongoing
Recalling Firm Cordis Corporation
City Miami Lakes
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-23
Initial Firm Notification of Consignee or Public Letter
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