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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 4,850
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.
Part of a larger recall action
This product is one of 2 recalled by Abbott under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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