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U.S. Department of Health and Human Services

Class 2 Device Recall DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRAAORTIC BALLOON CATHETER AND CS300 IABP CONTROL SYSTEM

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 Class 2 Device Recall DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRAAORTIC BALLOON CATHETER AND CS300 IABP CONTROL SYSTEMsee related information
Date Initiated by FirmFebruary 04, 2009
Date PostedApril 15, 2009
Recall Status1 Terminated 3 on August 11, 2009
Recall NumberZ-1198-2009
Recall Event ID 51178
510(K)NumberK063525 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductLow-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
Code Information Part Number: 0012-00-1589-03 Rev. C, RAM 0827.
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-0011
For Additional Information ContactThomas Brennan
973-244-6100
Manufacturer Reason
for Recall		Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.
FDA Determined
Cause 2		Process design
ActionAn "Urgent Medical Device Recall" letter dated February 4, 2009 was delivered to affected consignees by Datascope Field Representatives. Direct questions to your local Sales/Service Representative or call the Datascope Corporation at 1-973-244-6314.
Quantity in Commerce20
DistributionNationwide Distribution -- states of IL and FL.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSP
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