FDA-Device2025-04-30Class II
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Abbott
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
2683
Manufactured in
5050 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2025Don't want to check this manually?
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