Z-1644-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- March 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2683
Product Description
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Reason for Recall
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI 00811806012926 Lots 9078966 9093895 9134623 9144113 9148110 9148579 9155868 9158302 9241591 9241593 10004059 10011461 10011462 10011463 10011465 10017790 10017792 10196106 10196119 10198795 10198801 10198889 10207472 10207503 10274454 10283818