Recall Z-1644-2025— Abbott

Name: FDA recall Z-1644-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-17

Class II · Ongoing

Class II FDA medical device recall by Abbott, initiated 2025-03-17. It names one FDA 510(k) clearance: K162228. Product: Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080. Reason: 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..

Recalling firm: Abbott
Classification: Class II
Status: Ongoing
Initiated: 2025-03-17
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K162228 — TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor·cleared 2016-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.