Medical devices maker Integra LifeSciences Corporation (IART) has reportedly initiated an urgent global recall of its NeuroBalloon Catheter. The U.S. Food and Drug Administration (FDA) is expected to classify it as a Class 1 recall for catheters, which is the most serious type of recall as the affected products can be potentially hazardous or even cause death.
The recall is based on overseas customer complaints, which state that these specific catheters could malfunction. Plainsboro, New Jersey-based Integra received 8 such complaints regarding the inflation or deflation of the balloon component of the device during use. However, no injuries were reported or documented.
The NeuroBalloon Catheter is designed for dilation of cerebral membrane fenestrations (surgical opening) during intracranial (within the skull) procedures. The violin-shaped device is not implanted and is removed and disposed following a surgery.
Based on an inspection by Integra, it was found that the malfunction (inflation or deflation) can exist during pre-implant testing by physicians or technicians or during use of the device. The company issued a voluntary recall of the affected batches on July 2, 2010, due to potential defects in the catheters.
Integra has distributed a total of 1,924 units of NeuroBalloon Catheter in the U.S. and internationally. Healthcare professionals and consumers have been instructed to report adverse events or product quality issues to the FDA’s MedWatch Adverse Event Reporting program.
Integra develops and markets surgical implants and medical instruments for neurosurgery, extremity reconstruction, orthopedics and general surgery in the U.S., Europe and the Asia Pacific. The company markets the NeuroBalloon Catheter through its Neurosciences product division, which accounted for roughly 37% of the company’s total sales in second-quarter fiscal 2010.
The recall is based on overseas customer complaints, which state that these specific catheters could malfunction. Plainsboro, New Jersey-based Integra received 8 such complaints regarding the inflation or deflation of the balloon component of the device during use. However, no injuries were reported or documented.
The NeuroBalloon Catheter is designed for dilation of cerebral membrane fenestrations (surgical opening) during intracranial (within the skull) procedures. The violin-shaped device is not implanted and is removed and disposed following a surgery.
Based on an inspection by Integra, it was found that the malfunction (inflation or deflation) can exist during pre-implant testing by physicians or technicians or during use of the device. The company issued a voluntary recall of the affected batches on July 2, 2010, due to potential defects in the catheters.
Integra has distributed a total of 1,924 units of NeuroBalloon Catheter in the U.S. and internationally. Healthcare professionals and consumers have been instructed to report adverse events or product quality issues to the FDA’s MedWatch Adverse Event Reporting program.
Integra develops and markets surgical implants and medical instruments for neurosurgery, extremity reconstruction, orthopedics and general surgery in the U.S., Europe and the Asia Pacific. The company markets the NeuroBalloon Catheter through its Neurosciences product division, which accounted for roughly 37% of the company’s total sales in second-quarter fiscal 2010.
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