FDAFDA · Food and drugs·Recall number Z-1396-2024
OptiCross Coronary Imaging Catheter, REF H749518080120
Published April 3, 2024 · Recall initiated: March 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- International distribution to the country of Japan.
- Lot
- UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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