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VolumeView
Edwards Lifesciences LLC · Model VLV6R520 · UDI-DI 00690103187007
KRB
Prescription
1
510(k) clearances
340
Adverse events (5 deaths)
4
Recalls
49
Facilities
Description
VOLUMEVIEW SET,5F,20CM,60",1P
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 |
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Get your free API keyRead the docsData 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.