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U.S. Department of Health and Human Services

Class 2 Device Recall OptiCross" 40 MHz Coronary Imaging Catheter

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  Class 2 Device Recall OptiCross" 40 MHz Coronary Imaging Catheter see related information
Date Initiated by Firm March 05, 2024
Date Posted March 28, 2024
Recall Status1 Open3, Classified
Recall Number Z-1396-2024
Recall Event ID 94162
510(K)Number K213593  K123621  
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 2		 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 and Original Applicant = BOSTON SCIENTIFIC CORP.
510(K)s with Product Code = OBJ and Original Applicant = Boston Scientific Corporation
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