DRNClass II

Device, Counter-pulsating, External

Cardiovascular · 21 CFR 870.5225

MDR events58All time

Recalls1All time

Registered firms11Currently listed

510(k) clearances34All time

Recent MDR events

58 adverse event reports on file

Event type breakdown

Injury47

Death6

Other3

Unspecified1

Malfunction1

Most-reported manufacturers

Vasomedical, Inc.34 Vasomedical Inc.10 Foshan Life Sciences4 Vamed Medical Instrument Co4 Vamed Medical Instruments Co. Ltd2 Vasomedical Inc2 Baxter Healthcare (sg)1 Unk1

Recalls

1 recall events for this product code

Cardiomedics Incorporated
TerminatedJul 7, 2009
Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
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.
Z-1582-2009 · View FDA record ↗

Registered firms

11 firms currently registered for this product code

510(k) clearances

34 clearances for this product code