OptiCross Coronary Imaging Catheter, REF H749518080120
Reported: April 3, 2024 Initiated: March 5, 2024 #Z-1396-2024
Product Description
OptiCross Coronary Imaging Catheter, REF H749518080120
Reason for Recall
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 239 units
- Distribution
- International distribution to the country of Japan.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
OptiCross Coronary Imaging Catheter, REF H749518080120. Recalled by Boston Scientific Corporation. Units affected: 239 units.
Why was this product recalled? ▼
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1396-2024.
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