Amplatzer TorqVue LP Delivery System Recall for Shaft Breach
Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential for serious injury (blood loss, air embolism) associated with a structural defect, meeting the Severe criterion.
Plain-English summary
Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System, Models 9-TVLP4F90/060 and 9-TVLP4F90/080. These devices may have a small breach in the proximal end of the shaft under the strain relief of the delivery system.
The breach is not visibly detectable, meaning it cannot be seen during use. This defect may lead to prolonged procedure time, blood loss, or air ingress with potential for air embolism.
The recall affects 4,850 units distributed nationwide in the United States and worldwide. Affected lot numbers are listed in FDA recall Z-1643-2025. Healthcare providers and patients who have received this device should contact Abbott or their healthcare provider for further instructions.
The recalled product
- Product
- Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
- Manufacturer
- Abbott
- Hazard
- structural-defect
- air-embolism
- blood-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Models: 1. 9-TVLP4F90/060
- UDI-DI 00811806011578 Lots 9206150 10040010 10068340 10227816 10341801
Distribution
Distributed nationwide across the United States.
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