Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amplatzer TorqVue LP Delivery System (TVLP) Recalled by Abbott Due to Device may have a small breach in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott directly.
Affected Products
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Quantity: 4,850
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott
Abbott has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report