Amplatzer TorqVue LP Delivery System — Class II medical device recall Z-1643-2025
Ongoing recall by Abbott, reported 2025-04-30, distributed nationwide. Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system
| Recall number | Z-1643-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2025-03-17 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 4,850 |
| UPC / GTIN / UDI-DI | 00811806011561, 00811806011578 |
| Lot numbers | 10005333, 10040010, 10068340, 10080103, 10092488, 10092519, 10212158, 10227816, 10248201, 10265245, 10333989, 10334851, 10341801, 10353324, 9-TVLP4F90/080, 9114256, 9125090, 9157327, 9206150, 9211450 |
| Model numbers | 9-TVLP4F90/060, 9-TVLP4F90/080 |
Product
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1643-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.