FDA Medical devices recall ·
Amplatzer TorqVue LP Catheter (TVLPC), Model no recall
- Recall number
- Z-1644-2025
- Date
- (initiated March 17, 2025)
- Company / brand
- Abbott
5050 Nathan Ln N, Plymouth, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2683
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1644-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.