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

Recall Z-0021-2024 — Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter

U.S. FDA — Device Enforcement · United States · 2023-07-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0021-2024
Date of alert
2023-07-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08714729244349
Reported risk: Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
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.