Z-2791-2018Class II

VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM

Name: Z-2791-2018 VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM
Creator: Cook Inc.
Published: 2018-05-31
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-05-31 / Terminated / root cause: sterility

FDA source

Cook Inc. began a recall of VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for... on 2018-05-31. FDA classified it as Class II and gives the reason as "This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2791-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-31
Posted: 2018-08-12
Terminated: 2019-04-11
Recalling firm: Cook Incorporated
Product: VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
Product code: NHC Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Reason for recall: This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: On May 31, 2018, the firm contacted the single customer (a distributor) who received the entirety of the affected lot, via email. The email alerted the customer that the lot failed endotoxin testing and instructed the customer to quarantine the lot immediately. The firm then conducted a teleconference with the distributor to further discuss interim controls for future lot release. The recalling firm requested return of the affected lot. The distributor returned the lot to the firm. The recalling firm stated that none of the product was distributed to end users.
Quantity in commerce: 250
Distribution: One distributor in Indiana; product was not further distributed to end users.
Product codes and lots: lot 8639185

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2791-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2791-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-11

Product code NHC

K011812Class IISpectrum Ventricular CatheterCook, Inc. / cleared 2001-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)