CLASS II Device recall · Reported 22 Aug 2018 · FDA Enforcement Report

VentriClear Ventricular Drainage Catheter Set recalled by Cook

Cook is recalling VentriClear Ventricular Drainage Catheter Set, distributed in Indiana. The recall was initiated on 31 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot 8639185

Quantity recalled250

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2791-2018
FDA event ID: 80492
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2018
FDA classified: 11 Aug 2018
Reported: 22 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

31 May 2018	Recall initiated by company
11 Aug 2018	Classified by FDA	+72 days
22 Aug 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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.

Where it was distributed

One distributor in Indiana; product was not further distributed to end users.

Indiana

Questions about this recall

Is VentriClear Ventricular Drainage Catheter Set recalled?

Yes. Cook recalled VentriClear Ventricular Drainage Catheter Set on 31 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2791-2018.

Why was it recalled?

Which lots are affected?

lot 8639185

Where was it sold?

One distributor in Indiana; product was not further distributed to end users.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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