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U.S. Department of Health and Human Services

Class 2 Device Recall System 98XT/98 IntraAortic Balloon Pump

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  Class 2 Device Recall System 98XT/98 IntraAortic Balloon Pump see related information
Date Initiated by Firm May 10, 2010
Date Posted June 21, 2010
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-1813-2010
Recall Event ID 55649
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product System 98XT/98 Intra-Aortic Balloon Pump

This product was only distributed in India and Hong Kong/China.
Code Information Product number 0998-00-0446-XX and 0998-00-0479-XX. SN# S8119767B8 S8119768B8 S8119769B8 S8119771B8 S8119773B8 S8119774B8 S8119775B8 S8119778B8 S8119780B8 S8119781B8 S8119782B8 S8119764B8 S8119766B8 S8119770B8 S8119772B8 S8119776B8 S8119779B8  
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-0011
For Additional Information Contact Kevin Crossen
973-244-6100
Manufacturer Reason
for Recall		 Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen.
FDA Determined
Cause 2		 Other
Action Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.
Quantity in Commerce 161 units total
Distribution Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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