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

Recall Z-1582-2022 — Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

U.S. FDA — Device Enforcement · United States · 2022-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1582-2022
Date of alert
2022-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08714729202486
Reported risk: The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
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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