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Open, Classified

OptiCross Coronary Imaging Catheter, REF H749518080120

FDA Recall Z-1396-2024 · Posted 2024-03-28

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeOBJ
Date Initiated2024-03-05
Product Quantity239 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

International distribution to the country of Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation · 2022-01-14K123621OPTICROSS 40 MHZ CORONARY IMAGING CATHETERBoston Scientific Corp · 2013-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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