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FDA Says Medtronic Catheter Alert Now a Class I Recall

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A health alert issued in June by Medtronic regarding problems with catheters used with its implantable intrathecal drug pumps has been deemed a Class I recall by the  Food & Drug Administration (FDA), the agency’s most serious type.  Medtronic says it 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. In one case, a patient died from acute baclofen withdrawal related to complications from an improperly connected catheter.

Neither the June health alert  nor the FDA’s classification Friday called on patients to have devices removed, and hospitals and doctors are not being asked to return unused products.   However, patients who experience the catheter problems described in the recall will require a surgical procedure for correction, Medtronic said.

According to Medtronic,  when there is an occlusion (misalignment during connection), the catheter port may become embedded in the inner wall of the connector seal, rather than aligning with the connector.  Improper attachment can result in catheter connector damage, leaks at the connection site, or catheter disconnection some time after implant.

Occlusion or disconnection of the catheter can cause a lack of therapeutic effect, a clinically significant or fatal drug overdose or a return of underlying symptoms, and drug withdrawal symptoms.  According to Medtronic’ s press release, patients receiving intrathecal baclofen therapy  are at higher risk for adverse events because  withdrawal from this drug  can lead to a life threatening condition if not treated promptly and effectively.

Medtronic’s intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine.  These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin. The Medtronic catheter recall involves the following models:  INDURA 1P Intrathecal Catheter, model 8709SC, Intrathecal Catheter, model 8731SC, Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.

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