Reported Apr 30, 2025 · Ongoing
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Abbott
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott · 5050 Nathan Ln N · Plymouth, MN · 55442-3209
Is this the product you have?
- Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
- Lot codes and dates
- UDI-DI 00811806012926 Lots
907896690938959134623914411391481109148579915586891583029241591924159310004059100114611001146210011463100114651001779010017792101961061019611910198795101988011019888910207472102075031027445410283818
- UDI-DI 00811806012926 Lots
- Amount recalled
- 2683
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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