FDA Issues Class-1 Recall of Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters

On September 26, 2008, the FDA issued a Class-1 Recall of all Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters.

This recall is being conducted due to potential misconnections of the Medtronic sutureless connector (“SC”) catheters from the catheter port on the pump. These misconnections have resulted in a blockage (occlusion) between the sutureless pump connector.

To date, Medtronic has received 83 reports of infusion system difficulties worldwide that have been attributed to either an occlusion or a disconnection of the sutureless catheter from the pump.

The clinical signs of a possible occlusion or disconnection may include a lack of therapeutic effect, a clinically significant or fatal drug overdose or a return of underlying symptoms, and drug withdrawal symptoms. Patients receiving intrathecal baclofen therapy (e.g. Lioresal® Intrathecal) are at higher risk for adverse events as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively.

If you or a loved one has been harmed as a result of a Medtronic catheter, please contact our law-firm immediately for a free consultation.