FDA Classifies Medtronic Voluntary February Recall for BioGlide Ventricular Snap Shunt Catheters (Models 27782, 27708 and 27802) as Class I

Date of Recall

2009-03-27

Recall Details

MINNEAPOLIS – March. 27, 2009 – Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) classified as Class I its voluntary recall action initiated on February 11, 2009 of its BioGlide® Ventricular Snap Shunt Catheter (Cat. #s 27782, 27708 and 27802) – the cerebral ventricular catheter component of a shunt for the treatment of hydrocephalus. FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." This recall action (applicable to units in the United States, Ireland and Australia) involved the retrieval of unused product and safety notification of implanted product of these three catalog numbers of Medtronic Cerebral Ventricular Catheters. Approximately 3,000 catheters have been distributed between 2002 and 2009. It is estimated that there are 300 unused catheters.

As of March 18, 2009, Medtronic completed contact with all users of these catheters. This was completed by visit from its field personnel delivering the recall notification and to retrieve unused products. In addition, Medtronic has notified all its U.S. customers even though they may not have received the affected product. Patients with the implanted shunt system not experiencing symptoms of shunt malfunction should continue to be managed under the standard patient management protocols. If a disconnection occurs,

Patients may present with a return of the symptoms of hydrocephalus and should be assessed in accordance with standard of care for assessment of shunt malfunction.

The recall involved the following models:

• Innervision Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27782
• Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27802
• Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27708

It has been determined from nine reports of disconnected catheters requiring revision surgery, that the listed ventricular catheters may become detached from the snap base assembly after implantation and that this condition may increase the need for emergency revision surgery. There have been no reports of patient death or permanent serious injury as a result of this issue.

Consequences for a patient with failure of a ventricular catheter may include: nausea, vomiting, headache, lethargy, change in mental status, seizures, visual disturbance, and other more serious conditions. Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday – Friday, 8 a.m. to 5 p.m. CDT.

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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