Integra LifeSciences Corp. issued a global recall of its NeuroBalloon catheter.
The Plainsboro, N.J.-based holding company said it received a total of eight complaints, all from outside the U.S., regarding the inflation or deflation of the device.
Integra distributed 1,924 units in the U.S. and internationally, and it notified distributors and customers of the intracranial device about the possible defect July 2, the company said.
The Food & Drug Administration is expected to issue a Class I recall for the catheters, because the devices’ malfunctions "involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
The catalog number of the recalled NeuroBalloon catheters is 7CBD10; the recall includes lot identifications 0157983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630 and 0161857.
Integra said healthcare providers with questions regarding the product should call 1-800-654-2873 and follow the "returns and repairs" prompt.
