FDAFDA · Food and drugs·Recall number Z-1643-2025
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Published April 30, 2025 · Recall initiated: March 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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