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U.S. Department of Health and Human Services

Class 1 Device Recall Datascope System 98/98xt, CS 100/CS100i and CS 300 IntraAortic Balloon Pump

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  Class 1 Device Recall Datascope System 98/98xt, CS 100/CS100i and CS 300 IntraAortic Balloon Pump see related information
Date Initiated by Firm March 21, 2014
Date Posted May 21, 2014
Recall Status1 Terminated 3 on March 20, 2018
Recall Number Z-1523-2014
Recall Event ID 67815
510(K)Number K965236  K031636  K063525  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Code Information IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx 
Recalling Firm/
Maquet Datascope Corp - Cardiac Assist Division
1300 MacArthur Blvd.
Mahwah NJ 07430-2052
For Additional Information Contact Ms. Karen LeFevere
Manufacturer Reason
for Recall
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Maquet Inc. sent an Urgent Medical Device Field Correction letter dated March 21, 2014, to all affected customers. The letter identified the affected product, problem, and actions to be taken.. Customers were instructed that their Service Representatiave would contact them to schedule the replacement of the fan assembly at no cost to the customer. Upon completion customers were requested to sign a service repair order to verify satisfactory completion of the work. Customers with questions within Puerto Rico, were instructed to contact Technical Support in Mexico at +52-55-9000-8970, ext 104. For questions regarding this recall call 973-709-7652. A field correction letter was sent out on April 15, 2014 to additional consignees that did not receive the March 15, 2014 letter. Maquet issued press on May 9, 2014.
Quantity in Commerce 11,881 units (US 5183 and OUS 6698)
Distribution Worldwide Distribution - USA (nationwide) and approximately 104 countries.
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.