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VentriClear
COOK INCORPORATED · Model G44130 · UDI-DI 00827002441309
3
510(k) clearances
44
Adverse events (1 deaths)
2
Recalls
3
Facilities
Description
VentriClear II Ventricular Drainage Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-31 | Cook Inc. | This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflamm |
| 2015-11-19 | Cook Inc. | Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result |
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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.