Abbott: Device Recall

Recall #Z-1643-2025 · 03/17/2025

Class II: Risk

Recall Details

Recall Number: Z-1643-2025
Classification: Class II
Product Type: Device
Recalling Firm: Abbott
Status: Ongoing
Date Initiated: 03/17/2025
Location: Plymouth, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,850

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.

Product Description

Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by Abbott

Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I: Dangerous 09/10/2025

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

View all recalls by Abbott →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.