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U.S. Department of Health and Human Services

Class 2 Device Recall CardiAssist

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  Class 2 Device Recall CardiAssist see related information
Date Initiated by Firm April 09, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on August 27, 2012
Recall Number Z-1582-2009
Recall Event ID 52223
510(K)Number K050172  
Product Classification circulatory assist device - Product Code DRN
Product Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
Code Information CardioAssist Model 4000 Serial 4018
Recalling Firm/
Manufacturer		 Cardiomedics Incorporated
7 Whatney
Suite B
Irvine CA 92618-2839
For Additional Information Contact
949-863-2500
Manufacturer Reason
for Recall		 Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.
FDA Determined
Cause 2		 Software design
Action Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.
Quantity in Commerce 1
Distribution Florida
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 = DRN and Original Applicant = CARDIOMEDICS, INC.
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