Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk
Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and 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: The FDA classified this as a Class II recall. The potential hazards—air embolism, blood loss, and prolonged procedures—represent serious risks of harm in a cardiovascular device used during invasive procedures, meeting the Class II with significant injury risk criterion.
Plain-English summary
Abbott is recalling the Amplatzer TorqVue LP Catheter, Model no. 9-TVLPC4F90/080 (UDI-DI 00811806012926), due to a potential small breach in the proximal end of the shaft under the strain relief of the delivery system. The breach is not visibly detectable.
The defect may lead to prolonged procedure time, blood loss, or air ingress with potential for air embolism. The recall affects 2,683 units distributed nationwide in the US and worldwide. Affected lot numbers include 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, and 10283818.
Healthcare facilities and users should contact Abbott for device replacement or return instructions.
The recalled product
- Product
- Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
- Manufacturer
- Abbott
- Affected units
- 2,683
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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