Z-1507-2013 Class II Terminated
FDA device recall Z-1507-2013 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: 23 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
- 23 units
Product Description
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
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
27 Catalog Numbers FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1507-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026