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U.S. Department of Health and Human Services

Class 2 Device Recall CS300 IntraAortic Balloon Pump

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  Class 2 Device Recall CS300 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-1812-2010
Recall Event ID 55649
510(K)Number K063525  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product CS300 Intra-Aortic Balloon Pump
Code Information Product number 0998-00-3013-XX SN# SI126162D8 SI120003C8 SI122070C8 SI147171J8 SI124922D8 SI118561B8 SI121095C8 SI121099C8 SI122072C8 SI118566B8 SI119984C8 SI119986C8 SI119994C8 SI119997C8 SI120015C8 SI120021C8 SI120022C8 SI121087C8 SI119989C8 SI118559B8 SI119999C8 SI120000C8 SI120001C8 SI120005C8 SI120009C8 SI120017C8 SI121091C8 SI121100C8 SI124933D8 SI121090C8 SI120008C8 SI124911D8 SI124918D8 SI120004C8 SI120018C8 SI120020C8 SI121085C8 SI121097C8 SI121098C8 SI121103C8 SI121104C8 SI121107C8 SI121117C8 SI122075C8 SI120023C8 SI120019C8 SI121115C8 SI121119C8 SI122073C8 SI120006C8 SI120013C8 SI120014C8 SI121081C8 SI121082C8 SI121083C8 SI121094C8 SI121102C8. International: SI118567B8 SI118558B8 SI135828G8 SI118560B8 SI118565B8 SI119992C8 SI119987C8 SI119988C8 SI124910D8 SI135278G8 SI118562B8 SI119995C8 SI119985C8 SI118563B8 SI121084C8 S8119777B8 SI124923D8 SI121089C8 SI124939D8 SI124937D8 SI118564B8 SI124915D8 SI119991C8 SI119998C8 SI121096C8 SI158367D9  SI124920D8.    
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 units
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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