The Recall Desk
SevereFDA (Devices)·Z-1644-2025·Announced 2025-04-30

Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. The potential hazards—air embolism, blood loss, and prolonged procedures—represent serious risks of harm in a cardiovascular device used during invasive procedures, meeting the Class II with significant injury risk criterion.

Plain-English summary

Abbott is recalling the Amplatzer TorqVue LP Catheter, Model no. 9-TVLPC4F90/080 (UDI-DI 00811806012926), due to a potential small breach in the proximal end of the shaft under the strain relief of the delivery system. The breach is not visibly detectable.

The defect may lead to prolonged procedure time, blood loss, or air ingress with potential for air embolism. The recall affects 2,683 units distributed nationwide in the US and worldwide. Affected lot numbers include 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, and 10283818.

Healthcare facilities and users should contact Abbott for device replacement or return instructions.

The recalled product

Product
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Manufacturer
Abbott
Category
Medical Device — Cardiovascular / Catheter
Hazard
  • air-embolism
  • blood-loss
  • device-defect

Distribution

Distributed nationwide across the United States.

Related recalls

Same category