Home › Edwards Lifesciences LLC › VOLUMEVIEW

VOLUMEVIEW

Edwards Lifesciences LLC · Model VLV8R5 · UDI-DI 07460691950481

KRB DRS Prescription

510(k) clearances

340

Adverse events (5 deaths)

Recalls

Facilities

Description

VOLUMEVIEW SENSOR,84",5P,RED C

Recalls

Date	Firm	Reason
2018-10-05	ICU Medical, Inc.	Potential for leakage due to defect in the thermoset check valve component.
2018-10-05	ICU Medical, Inc.	Potential for leakage due to defect in the thermoset check valve component.
2018-10-05	ICU Medical, Inc.	Potential for leakage due to defect in the thermoset check valve component.
2014-11-04	Pulsion Medical Inc	Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.