Cook recalls VentriClear Ventricular Drainage Catheter Set (lot : 8639185) due to endotoxin testing failure. This may cause immune reactions from mild fever to life-threatening systemic inflammation.
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).
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook VentriClear Drainage Catheter Recall: Endotoxin Failure Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70920-cook-ventriclear-drainage-catheter-recall-endotoxin-failure-risk. Based on FDA recall #Z-2791-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2791-2018%22&limit=1).
The Food and Drug Administration announced on May 31, 2018, that Cook Inc. voluntarily recalled the VentriClear Ventricular Drainage Catheter Set due to a failure in endotoxin testing. The agency classified this Class II recall as terminated.
How to tell if you have it
Brand: Cook
Product: VentriClear Ventricular Drainage Catheter Set
Catalog No.: N-VVDC-01-ABRM
Lot code: 8639185
The hazard
The recalled lot failed endotoxin testing, which can lead to immune responses ranging from non-specific febrile reactions to life-threatening systemic inflammatory response syndrome (SIRS).
Context
GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Recent Cook recalls include the Flexor Check-Flo Introducer Ansel Modification recall on Nov. 12, 2021, and the Skinny Needle with Chiba Tip Recall on Oct. 13, 2021. Other recent recalls of similar products include the Getinge Thoracic Catheter Recall (Aug. 7, 2026), the Codman CerebroFlo EVD Catheter Recall (April 10, 2026), and the Medtronic Neurosurgery Ventriculostomy Kit Recall (June 17, 2026).
How to tell if you have this one
Check for the lot number 8639185 on the catheter packaging. This product was sold for short-term brain fluid drainage procedures.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the VentriClear Ventricular Drainage Catheter Set with lot number 8639185.
Where it went and when
Where it was distributed
Distributed in Indiana.
Listed by the agency
Not listed
FDA distribution: “One distributor in Indiana; product was not further distributed to end users.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2791-2018 (May 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2791-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.