Class 1 Recall: Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide

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.

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.

The ventricular catheter may become detached from the snap base assembly after implantation and may increase the need for emergency corrective surgery.

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.

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

• should stop implanting 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 at: http://wwwp.medtronic.com/Newsroom/ NewsReleaseDetails.do?itemId=1238091091955&lang=en_US

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 either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178