Recall Z-1582-2009 ยท DRN Device, Counter-Pulsating, External
Cardiomedics Incorporated
Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
| Date | Jul 7, 2009 (initiated Apr 9, 2009) |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5. |
| Quantity | 1 |
| Distribution | Florida |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050172 | CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 Cardiomedics, Inc., Mar 31, 2005 |