Amplatzer TorqVue recallZ-1643-2025 · Abbott · initiated Mar 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1643-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 17, 2025
- Posted by the FDA
- Apr 21, 2025
- Recalling firm
- Abbott
- Quantity
- 4,850
- Product code
- DQY
- FDA submissions
- K131063
- Distribution
- Worldwide - US Nationwide distribution.
Product description
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Amplatzer™ TorqVue™ 9-TVLP4F90/060St. Jude Medical, Inc. · CATHETER, PERCUTANEOUS1 recall4 reports
- Amplatzer™ TorqVue™ 9-TVLP4F90/080St. Jude Medical, Inc. · CATHETER, PERCUTANEOUS1 recall3 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96545).
- Z-1644-2025 · Open, ClassifiedAmplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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