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

Recall Z-1490-2023 — ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM

U.S. FDA — Device Enforcement · United States · 2023-03-24 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1490-2023
Date of alert
2023-03-24
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Cordis US Corp
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20705032053492
Reported risk: There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.