FDA-Device2025-04-30Class II
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
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
4,850
Manufactured in
5050 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1643-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief