FDA Device recall Z-1396-2024
OptiCross Coronary Imaging Catheter, REF H749518080120
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of OptiCross Coronary Imaging Catheter, REF H749518080120 by Boston Scientific, citing certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1396-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-05 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
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.
Identifiers
| code_info | UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1396-2024%22
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