Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
FDA device recall Z-1582-2009 · posted 2009-07-07 · Terminated
Recall details
- Recalling firm
- Cardiomedics Incorporated
- 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.
- Action taken
- Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DRN
- Quantity affected
- 1
- Distribution
- Florida
- Date initiated
- 2009-04-09
- Date posted
- 2009-07-07
- Date terminated
- 2012-08-27
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (K050172) | Cardiomedics, Inc. | 2005-03-31 |