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RenewTM NCP-5 External Counterpulsation System
RENEW GROUP PRIVATE LIMITED · Model NCP-5 · UDI-DI 08883000001640
DRN
Prescription
1
510(k) clearances
58
Adverse events (6 deaths)
1
Recalls
8
Facilities
Description
EXTERNAL COUNTERPULSATION SYSTEM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-04-09 | Cardiomedics Incorporated | 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 enou |
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