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U.S. Department of Health and Human Services

Class 2 Device Recall LINEAR 7.5Fr. 40cc IAB with APA

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 Class 2 Device Recall LINEAR 7.5Fr. 40cc IAB with APAsee related information
Date Initiated by FirmAugust 05, 2022
Date PostedOctober 24, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0131-2023
Recall Event ID 90913
510(K)NumberK041281 
Product Classification Ventricular (assist) bypass - Product Code DSQ
ProductLINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Code Information UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information ContactMarylou Insinga
973-709-7442
Manufacturer Reason
for Recall		The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.
FDA Determined
Cause 2		Labeling Change Control
ActionOn August 5, 2022, the firm notified affected customers via Urgent Field Safety Notice Medical Device Removal letters. Customers were instructed to examine their inventory for the affected product. Customers may return the product for full credit. The firm also informed customers that given current supply chain shortages that they are unable to commit to a timely replacement of affected catheters.
Quantity in Commerce4414 OUS
DistributionNo US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSQ
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