medical Class II Updated 2025-04-30

Abbott recalls Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90

Recalled Product

Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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