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U.S. Department of Health and Human Services

Class 1 Device Recall CS 100i IntraAortic Balloon Pump

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  Class 1 Device Recall CS 100i IntraAortic Balloon Pump see related information
Date Initiated by Firm June 16, 2017
Date Posted June 23, 2017
Recall Status1 Open3, Classified
Recall Number Z-2736-2017
Recall Event ID 77566
510(K)Number K031636  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product CS 100i Intra-Aortic Balloon Pump
Code Information 0998-UC-0446HXX 0998-UC-0479HXX
Recalling Firm/
Manufacturer
Maquet Datascope Corp - Cardiac Assist Division
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact
973-244-6138
Manufacturer Reason
for Recall
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
FDA Determined
Cause 2
Component design/selection
Action Datascope Corp/MAQUET issued a press release on June 16, 2017. Datascope Corp/MAQUET sent an Urgent Product Recall Letter on June 19, 2017, to their customers via FedEx next day delivery service. Pursuant to the WARNINGS section of our CS100i, CS100 or CS300 IABP Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy. Until the service is performed, we recommend the IABP be powered on prior to initiation of therapy to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office. Customers will be instructed to complete and return the attached Medical Device Field Correction Response Form via fax to 1-973-807-9217 or send via email to IABP2017@getinge.com.ABP2017@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. For U.S. customers with technical questions, please contact our Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST
Quantity in Commerce 12,319 units total
Distribution Worldwide Distribution - (in over 100 countries) US (Nationwide)
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 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) Database 510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.
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