Amplatzer TorqVue recallZ-1644-2025 · 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-1644-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 17, 2025
- Posted by the FDA
- Apr 21, 2025
- Recalling firm
- Abbott
- Quantity
- 2683
- Product code
- DQY
- FDA submissions
- K162228
- Distribution
- Worldwide - US Nationwide distribution.
Product description
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Amplatzer™ TorqVue™ 9-TVLPC4F90/080St. Jude Medical, Inc. · CATHETER, PERCUTANEOUS1 recall3 deaths9 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96545).
- Z-1643-2025 · Open, ClassifiedAmplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
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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