FDA Medical devices recall ·
Amplatzer TorqVue LP Delivery System (TVLP), Model nos recall
- Recall number
- Z-1643-2025
- 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
- 4,850
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
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
Models: 1. 9-TVLP4F90/060; UDI-DI 00811806011561 Lots 9114256 9125090 9157327 9211450 10005333 10080103 10092488 10092519 10212158 10248201 10265245 10333989 10334851 10353324 2. 9-TVLP4F90/080; UDI-DI 00811806011578 Lots 9206150 10040010 10068340 10227816 10341801
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-1643-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.