Boston Scientific Corporation OptiCross Coronary Imaging Catheter, REF H749518080120 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OptiCross Coronary Imaging Catheter, REF H749518080120
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
Products Sold
UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
Boston Scientific Corporation is recalling OptiCross Coronary Imaging Catheter, REF H749518080120 due to Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased im. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026