Z-1396-2024Class II

OptiCross Coronary Imaging Catheter, REF H749518080120

Name: Z-1396-2024 OptiCross Coronary Imaging Catheter, REF H749518080120
Creator: Boston Scientific Corporation
Published: 2024-03-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-03-05 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of OptiCross Coronary Imaging Catheter, REF H749518080120 on 2024-03-05. FDA classified it as Class II and gives the reason as "Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1396-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-05
Posted: 2024-03-28
Recalling firm: Boston Scientific Corporation
Product: OptiCross Coronary Imaging Catheter, REF H749518080120
Product code: OBJ Catheter, Ultrasound, Intravascular
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 239 units
Distribution: International distribution to the country of Japan.
Product codes and lots: UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1396-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28

Product code OBJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)