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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 SYSTEM see related information
Date Initiated by Firm February 04, 2009
Date Posted April 15, 2009
Recall Status1 Terminated 3 on August 11, 2009
Recall Number Z-1198-2009
Recall Event ID 51178
510(K)Number K063525  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Low-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 Contact Thomas 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
Action An "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 Commerce 20
Distribution Nationwide Distribution -- states of IL and FL.
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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