FDA Device recall Z-1643-2025
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
- FDA Device
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 by Abbott, citing 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 procedur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1643-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-17 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott |
| Distribution | US |
Product
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Reason
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.
Identifiers
| code_info | Models: 1. 9-TVLP4F90/060; UDI-DI 00811806011561 Lots 9114256 9125090 9157327 9211450 10005333 10080103 10092488 1009…Models: 1. 9-TVLP4F90/060; UDI-DI 00811806011561 Lots 9114256 9125090 9157327 9211450 10005333 10080103 10092488 10092519 10212158 10248201 10265245 10333989 10334851 10353324 2. 9-TVLP4F90/080; UDI-DI 00811806011578 Lots 9206150 10040010 10068340 10227816 10341801 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1643-2025%22
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