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Bladder Set, X-Small

VASOMEDICAL, INC. · Model Model Lumenair · UDI-DI 00817980021082

DRN Prescription
1
510(k) clearances
58
Adverse events (6 deaths)
1
Recalls
8
Facilities

Description

Bladder Set, X-Small

Recalls

DateFirmReason
2009-04-09Cardiomedics IncorporatedCuff 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.