FDA recall Z-1644-2025

Abbott · Class II · device

Product

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

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-03-17
Report date: 2025-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2025