FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: OptiCross Coronary Imaging Catheter, REF H749518080120
- Recall number
- Z-1396-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- OptiCross Coronary Imaging Catheter, REF H749518080120
- Status
- Open, Classified
- Initiated
- 2024-03-05
- Posted
- 2024-03-28
- Terminated
- not on file
- Reason
- Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
- Root cause
- Process control
- Action
- Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/05/2024 via overnight delivery. The notice explained the issue, potential risk, and requested the consignee immediately discontinue use, segregate, and respond pending return of the device.
- Quantity
- 239 units
- Distribution
- International distribution to the country of Japan.
- Lot, serial or model codes
- UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
- 510(k) numbers
- ["K123621","K213593"]
- PMA numbers
- not on file
- Product code
- OBJ
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28