Z-1396-2024 Class II Ongoing
FDA device recall Z-1396-2024 was initiated by Boston Scientific Corporation on Mar 5, 2024 and is designated Class II. Reason for recall: Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness. The recall status is ongoing. Affected quantity: 239 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Mar 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 239 units
Product Description
OptiCross Coronary Imaging Catheter, REF H749518080120
Reason for Recall
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Distribution Pattern
International distribution to the country of Japan.
Code Information
UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1396-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026