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Medical Devices

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Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide

Recall Class:
 Class I
Date Recall
Initiated:
 February 12, 2009
Product:

Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide

Catalog numbers: 27782, 27708 and 27802 (All Versions, All Lot Numbers)

This product was manufactured from October, 2002 through December, 2008 and distributed from April 29, 2004 through December 12, 2008.
Use:
 The ventricular catheters are part of a surgically implanted system (shunt) that redirects excess fluid from the brain to another part of the body. Shunts are used to treat hydrocephalus, which is an excess accumulation of cerebrospinal fluid in the brain.
Recalling Firm:
 Medtronic Neurologic Technologies
Respiratory and Monitoring Solutions
125 Cremona Drive
Goleta, California 93117
Reason for Recall:
 The ventricular catheter may become detached from the snap base assembly after implantation and may increase the need for emergency corrective surgery.
Public Contact:

Patients may contact Medtronic Patient Services at 1-800-510-6735, Monday through Friday, 8 a.m. to 5 p.m. Central Standard Time. Physicians with questions relating to this issue should contact Medtronic at 1-800-328-0810, Monday through Friday, 8 a.m. to 5 p.m. Central Standard Time.

Patients with questions are encouraged to talk with their physicians.
FDA District:
 Los Angeles
FDA Comments:

Medtronic sent their customers a recall notice on February 13, 2009 informing them that they:

  • should stop using the device
  • need to return all unused products to the company
  • are required to account for each used (implanted) device
  • are to advise surgeons about the recall

Each customer will receive an individualized Customer Product Reconciliation Form provided by their Medtronic Sales Representative for determining the status of any product shipped to them.

For more information about this recall, please see the company’s press release.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program.  See the nearby link to MedWatch.
    
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