Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1644-2025 — Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

U.S. FDA — Device Enforcement · United States · 2025-03-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1644-2025
Date of alert
2025-03-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00811806012926
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.