Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following designation
FDA device recall Z-1284-2012 · posted 2012-03-23 · Terminated
Recall details
- Recalling firm
- Medtronic Vascular, Inc.
- Reason for recall
- Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism.
- Action taken
- Medtronic, Inc. sent an Urgent Medical Device Safety Information letter dated February 2012, to all affected customers. The letter identified the product, the problem, and the corrective action taken by Medtronic. Medtronic updated the Instructions for Use (IFU) manual. For questions regarding this recall call 707-566-1110.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MIH
- Quantity affected
- 1523 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-02-21
- Date posted
- 2012-03-23
- Date terminated
- 2012-07-12
- Location
- Santa Rosa, CA
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