Recalled Integra Catheter Distributed in Florida

The United States Food and Drug Administration has announced that Plainsboro, New Jersey based Integra LifeSciences Corporation is recalling their NeuroBalloon Catheter. This is expected to be designated a Class I recall by the FDA, and this classification is reserved for instances when a defective product poses a “reasonable probability” of causing serious health problems, including death.

The NeuroBalloon Catheter is used during brain surgery to keep the surgical openings of the cerebral membrane dilated during the procedure. It is only used for this purpose and it is intended to be discarded after use. Eight complaints have been reported to Integra thus far, and at present none of them have resulted in any injuries according to the press release that is being distributed by the FDA.

The recall is global, for the most part affecting the European Union and the United States. Out of a total of 1,924 NeuroBalloon Catheters being recalled, 258 of them have been distributed in the United States. States that have received them include Florida as well as neighboring Georgia, New York, Pennsylvania, New Jersey, and 16 others.

We try to keep our readers abreast of product defect recalls of all types, so we encourage everyone to check back often because we will be passing recall information along as it becomes available on a consistent basis.

Anyone who would like to share information with the FDA about any difficulties that they have experienced using the NeuroBalloon Catheter can file a report with the FDA’s MedWatch Adverse Event Reporting program. This can be done online by clicking here.

If you or someone you know has been injured by a defective product, please contact us at 727-848-8892 to schedule a free consultation.