Z-0290-2022 Class II Ongoing
FDA device recall Z-0290-2022 was initiated by Medtronic Vascular, Inc. on October 15, 2021 and is designated Class II. Reason for recall: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube The recall status is ongoing. Affected quantity: 2 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- October 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 devices
Product Description
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Reason for Recall
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Code Information
Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639