Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-1396-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

OptiCross Coronary Imaging Catheter, REF H749518080120

Product Classification:

Class II

Date Initiated: March 5, 2024

Date Posted: April 3, 2024

Recall Number: Z-1396-2024

Event ID: 94162

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.

Status: Ongoing

Product Quantity: 239 units

Code Information:

UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286

Distribution Pattern:

International distribution to the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated