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

Recall Z-1396-2024 — OptiCross Coronary Imaging Catheter, REF H749518080120

U.S. FDA — Device Enforcement · United States · 2024-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1396-2024
Date of alert
2024-03-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08714729938415
Reported risk: Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
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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