Z-1582-2009

Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000

Name: Z-1582-2009 Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000
Creator: Cardiomedics Incorporated
Published: 2009-04-09
License: https://open.fda.gov/license/

Cardiomedics Incorporated / initiated 2009-04-09 / Terminated / root cause: software

FDA source

Cardiomedics Incorporated began a recall of Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000 on 2009-04-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1582-2009
Status: Terminated
Initiated: 2009-04-09
Posted: 2009-07-07
Terminated: 2012-08-27
Recalling firm: Cardiomedics Incorporated
Product: Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
Product code: DRN Device, Counter-Pulsating, External
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: CardioAssist Model 4000 Serial 4018

Product code DRN

K050172Class IICardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. / cleared 2005-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)