FDA Medical Device Recalls (openFDA)
Cook Inc.: 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.
- Recall number
- Z-2791-2018
- Recalling firm
- Cook Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-05-31
- Posted
- not on file
- Terminated
- 2019-04-11
- Reason
- 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
- 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
- 250
- Distribution
- One distributor in Indiana; product was not further distributed to end users.
- Lot, serial or model codes
- lot 8639185
- 510(k) numbers
- ["K011812"]
- PMA numbers
- not on file
- Product code
- NHC
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28