Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
FDA device recall Z-1643-2025 · posted 2025-04-21 · Open, Classified
Recall details
- Recalling firm
- Abbott
- 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.
- Action taken
- On March 17, 2025, the firm notified customers via hand-delivered customer communications titled "Urgent Medical Device Recall." Customers were instructed to share the notice with applicable personnel and to return any remaining unused devices from impacted lots. Abbott representatives will assist with product return and replenishment. If you have any questions, please contact your local Sales Representative or Abbott Support at 1-800-544-1664.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DQY
- Quantity affected
- 4,850
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2025-03-17
- Date posted
- 2025-04-21
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPLATZER TORQ VUE LP DELIVERY SYSTEM (K131063) | St Jude Medical | 2013-08-15 |