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U.S. Department of Health and Human Services

Class 2 Device Recall CS100 IntraAortic Balloon Pump.

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  Class 2 Device Recall CS100 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-1811-2010
Recall Event ID 55649
510(K)Number K031636  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product CS100 Intra-Aortic Balloon Pump.
Code Information Product number 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.   
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 total devices
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.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.
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