WASHINGTON, March 30 (UPI) -- The U.S. Food and Drug Administration says it has classified the February recall of Medtronic Inc. BioGlide-model catheters as a "Class 1" recall.
The cerebral ventricular catheter component of a shunt is used in the treatment of hydrocephalus. FDA defines a Class 1 recall as "a situation in which there is a reasonable probability that the use of or exposure to a (recalled) product will cause serious adverse health consequences or death."
The recall involved units distributed in the United States, Ireland and Australia with Catalog Nos. 27782, 27802 and 27708.
The FDA said patients with the implanted shunt system not experiencing symptoms of shunt malfunction should continue to be managed under the standard patient management protocols.
It was determined the catheters might become detached from the snap base assembly after implantation, thereby increasing the need for emergency revision surgery.
The federal agency said consequences for a patient with failure of a ventricular catheter can include nausea, vomiting, headache, lethargy, change in mental status, seizures, visual disturbance and other more serious conditions.
Patients with questions can contact their physician or Medtronic Patient Services at 800-510-6735 Monday-Friday, 8 a.m. to 5 p.m. CDT.
