Class 2 Device Recall OptiCross" 40 MHz Coronary Imaging Catheter

• Date Initiated by Firm: March 05, 2024
• Date Posted: March 28, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1396-2024
• Recall Event ID: 94162
• 510(K)Number: K123621 K213593
• Product Classification: Catheter, ultrasound, intravascular - Product Code OBJ
• Product: OptiCross Coronary Imaging Catheter, REF H749518080120
• Code Information: UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Rebecca KinKead Rubio; 763-494-1133
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OBJ; 510(K)s with Product Code = OBJ