Integra Recalls Brain CathetersAug 26, 2010 | Parker Waichman LLP
Earlier this week we wrote that the U.S. Food and Drug Administration (FDA) announced that Integra LifeSciences Corporation of Plainsboro, New Jersey, initiated a voluntary, urgent, worldwide recall of its NeuroBalloon Catheter. Now, Zacks Investment Research reports that the FDA is expected to classify this recall as a Class I, the agency’s most serious classification since the action involves situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
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. Integra has received a total of eight complaints regarding the inflation or deflation of the NeuroBalloon Catheter. All complaints occurred outside the US; no patient injuries have been reported. The customer complaints, notes Zacks Investment Research, mean that these catheters have the potential to malfunction.
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. Zacks Investment Research pointed out that either physicians or technicians can conduct pre-implant testing and that the malfunction could occur during use.
Integra, which markets the recalled NeuroBalloon Catheter via its Neurosciences group, is a developer and marketer of surgical implant and medical instruments used in, said Zacks Investment Research, “neurosurgery, extremity reconstruction, orthopedics, and general surgery in the U.S., Europe, and the Asia Pacific.” The NeuroBalloon Catheter accounted for about 37 percent of Integra’s total sales for second quarter in fiscal year 2010, added Zacks.
The NeuroBalloon Catheter is intended for dilation of cerebral membrane fenestrations under direct or endoscopic visualization during intracranial procedures and is not implanted, but is removed and discarded following surgery.
In the US, the recalled NeuroBalloon Catheter was distributed by Integra in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Pennsylvania, Texas, Utah, and Vermont. Overseas, the product was distributed in 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. Integra can be reached 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: 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