Amplatzer TorqVue LP Catheter recall
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Why was Amplatzer TorqVue LP Catheter 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
- Recalling firm
- Abbott
- Quantity
- 2683
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)