Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Sizes: 9 CM in length, REF (240)

FDA device recall Z-1129-2009 · posted 2009-03-27 · Terminated

Recall details

Recalling firm

Medtronic Neurosurgery

Reason for recall

The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Action taken

An Urgent - Medical Device Recall notification was sent on February 13,2009 to the attention of risk managers, advising them to cease use of the Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782 ( all versions and all lot numbers), the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27802 ( all versions and all lot numbers), and the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27708 ( all version and all lot numbers). Each customer is to cease the use of the listed product and any unused unit needs to be returned to Medtronic. Further, each account is required to account for product used/implanted and to advise surgeons of the recall information. Each account will recieved an individualized Customer Product Reconciliation Form provided by their Medtronic Sales Representative for determining the status of any product shipped to them.

Root cause

Device Design

Status

Terminated

Product code

JXG

Quantity affected

3048 of all units

Distribution

Worldwide Distribution -- USA, Ireland, and Australia.

Date initiated

2009-02-12

Date posted

2009-03-27

Date terminated

2010-11-08

Location

Goleta, CA

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