Recall archive / FDA device enforcement
OptiCross Coronary Imaging Catheter, REF H749518080120 — FDA record Z-1396-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- OptiCross Coronary Imaging Catheter, REF H749518080120
- Reason
- Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 239 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1396-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Japan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 3, 2024
- Recall initiation date
- Mar 5, 2024
- Center classification date
- Mar 28, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.