Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect
Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a cardiovascular imaging device. The defect is a manufacturing error resulting in decreased image brightness, a functional degradation that could affect clinical utility. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm medical devices where injury has not yet been reported are classified as High.
Plain-English summary
Boston Scientific Corporation has recalled certain batches of OptiCross 40MHz Coronary Imaging Catheters due to a manufacturing defect. These units were produced using an incorrect voltage setting, which may result in decreased image brightness during imaging procedures.
The recall affects catheters with lot numbers 32426901, 32429407, and 32625286. A total of 239 units have been distributed internationally, primarily to Japan. The affected devices are identified by REF H749518080120 and UDI/DI 08714729938415.
Patients and healthcare providers who have received or are using affected units should contact Boston Scientific or their healthcare provider for information regarding replacement or corrective action. No injuries or illnesses have been reported to date.
The recalled product
- Product
- OptiCross Coronary Imaging Catheter, REF H749518080120
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 239
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 08714729938415
- Lot Numbers: 32426901
- 32429407
- 32625286
Distribution
Distribution scope not specified by the agency.
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