OptiCross Coronary Imaging Catheter recall
OptiCross Coronary Imaging Catheter, REF H749518080120
Why was OptiCross Coronary Imaging Catheter recalled?
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
- Product
- OptiCross Coronary Imaging Catheter, REF H749518080120
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 239 units
- Distribution
- International distribution to the country of Japan.
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)