Abbott: Medical Device Recall in 2025 - (Recall #: Z-1644-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 17, 2025

Date Posted: April 30, 2025

Recall Number: Z-1644-2025

Event ID: 96545

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 2683

Code Information:

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

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated