Recall Z-1396-2024— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-03-05. It names 2 FDA 510(k) clearances: K213593, K123621. Product: OptiCross Coronary Imaging Catheter, REF H749518080120. Reason: Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-05
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K213593 — OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
- K123621 — OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.