—#206479

Product

OptiCross Coronary Imaging Catheter, REF H749518080120

FDA product code: OBJ — Catheter, Ultrasound, Intravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K123621, K213593
Affected lot / code info: UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286

Why it was recalled

Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/05/2024 via overnight delivery. The notice explained the issue, potential risk, and requested the consignee immediately discontinue use, segregate, and respond pending return of the device.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: International distribution to the country of Japan.

Timeline

Recall initiated: 2024-03-05
Posted by FDA: 2024-03-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206479. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.