Medtronic Infusion Pump Catheter Recall Due to Mislabeled Leads

The FDA has issued a Class I recall for Medtronic Sutureless Connector (SC) intrathecal catheters because they may be incorrectly labeled as being compatible with the IsoMed Infusion pump, a drug delivery system for which the catheters were not designed.

Medtronic sent out a letter to physicians warning that the catheters were mistakenly labeled as being compatible with the IsoMed Pump Model 8472, which is no longer marketed or manufactured. The FDA notified Medtronic on September 14 that it considers the notification a Class I medical device recall, because accidental use of the catheters with the wrong drug pump carries a reasonable probability of resulting in serious injury or death.

Medtronic has received at least 10 reports involving patients who used the catheters with IsoMed Pumps. In all ten cases the patients required medical intervention. One patient died two days after incorrectly using the catheters with the IsoMed Pump, but Medtronic said it cannot be certain the death was tied to the catheter’s misuse.

The recalled infusion pump catheters include the SC Catheter and Revision Kit Models 8709SC, 8731SC, 8578 and 8596SC. The catheters are incorrectly labeled as being compatible with the IsoMed Pump Model 8472, which was discontinued in September 2008 as part of a planned phase-out.

The catheter does not completely connect to the IsoMed pump, although it may appear to be securely connected. This can lead to drug or cerebrospinal fluid (CSF) leakage into surrounding tissue and can result in tissue damage, severe headaches and fatal drug overdoses. Medtronic indicated that patients undergoing intrathecal baclofen therapy were at high risk. The IsoMed pump is not approved by the FDA for use with baclofen, and baclofen withdrawal can lead to life-threatening health conditions.

The FDA and Medtronic warned physicians not to use the catheters with the IsoMed Pump. If a catheter has been used with the pump, it should not be reused, as the catheter may have been permanently damaged by its connection to the IsoMed Pump. Any patients using the devices who believe they are suffering from symptoms of withdrawal should immediately seek medical attention.

On July 10, 2009, Medtronic, Inc. recalled about 3 million disposable infusion sets designed for use with their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially resulting in injury or death. At that time, the company estimated that about 2%, or 60,000, of the sets from a lot number starting with “8” may be defective.