Integra LifeSciences Corporation of Plainsboro, New Jersey, has initiated a worldwide recall of its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">NeuroBalloon Catheter, the U.S. Food and Drug Administration (FDA) just announced.
A total of 1,924 Integra LifeSciences NeuroBalloon Catheters were distributed: 258 in the United States; 1,586 in the European Union; and 80 in other countries. A total of eight complaints regarding the inflation or deflation of the NeuroBalloon Catheter have been received by Integra. All complaints occurred outside the US; no patient injuries have been reported.
As a result of an investigation performed by Integra, it was determined that this condition could exist during pre-implant testing or during the procedure.
Integra issued a voluntary recall of the affected lots of the NeuroBalloon Catheter on July 2, 2010. The FDA is expected to classify this recall as a Class I recall, the FDAâ€™s most serious recall which involves situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
The NeuroBalloon Catheter is intended for dilation of cerebral membrane fenestrations under direct or endoscopic visualization during intracranial procedures. The NeuroBalloon Catheter is not implanted and is removed and discarded after surgery.
The potential issue should be readily detectable since complications concerning inflation or deflation of the balloon component can be immediately observed by the physician or technician prior to or during use; therefore, if any of the products from the affected lots have been used in patients, Integra does not recommend any change to the standard post-surgical follow-up plan for those patients. The patientâ€™s physician should continue to exercise his/her clinical judgment with any periodic patient follow-up.
The NeuroBalloon Catheter recall includes the following catalog and lot identifications:
â€¢ Catalog Number: 7CBD10
â€¢ Lot Numbers: 0157983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, 0161857
The recalled NeuroBalloon Catheter was distributed by Integra (USA) in: USA (Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Pennsylvania, Texas, Utah, and Vermont); Argentina; Australia; Canada; France; Taiwan; and the United Kingdom.
Integra notified its distributors and customers by overnight mail on July 2, 2010 and arranged for return of all unused recalled products.
Healthcare practitioners with questions may contact the company at 1-800-654-2873 (Follow Returns & Repairs Prompt) Monday through Friday, 8:00 am to 5:00 pm (Eastern Standard Time).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail.â€¨â€¨Online: www.fda.gov/medwatch/report.htm; regular mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch P.O. Box 3002, Rockville, Maryland, 20847-3002