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Terminated

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

FDA Recall Z-1582-2009 · Posted 2009-07-07

Recalling FirmCardiomedics Incorporated
Recall StatusTerminated
Product CodeDRN
Date Initiated2009-04-09
Date Terminated2012-08-27
Product Quantity1

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.

Firm Action

Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.

Root Cause

Software design

Distribution Pattern

Florida

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050172CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000Cardiomedics, Inc. · 2005-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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