Boston Scientific recalls OptiCross Coronary Imaging Catheters with incorrect voltage settings that may cause decreased image brightness. Affected units include specific lot numbers and UDI/DI codes.
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Boston Scientific is recalling certain Opti:Cross Coronary Imaging Catheters due to a manufacturing issue that may cause decreased image brightness. This could affect medical imaging accuracy during procedures.
The catheters were manufactured with an incorrect voltage setting, which reduces image brightness. This could lead to less accurate imaging during coronary procedures, potentially affecting diagnosis or treatment decisions.
Healthcare professionals using the recalled catheters for coronary imaging procedures are most at risk. Patients receiving these procedures may also be affected if the catheter is used incorrectly.
Check for the lot numbers 32426901, 32429407, or 32625286 on the catheter packaging. Also look for the UDI/DI code 08714729938415.
Review the lot numbers and UDI/DI code on the catheter packaging to confirm if it is affected.
Certain batches were manufactured with an incorrect voltage setting, which may result in decreased image brightness.
Check for lot numbers 32426901, 32429407, or 32625286 and the UDI/DI code 08714729938415.
The recall does not require immediate discontinuation; affected units should be checked for the specific lot numbers and UDI/DI code.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1396-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1396-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
