Medtronic Issues Class I Recall of Sutureless Catheter and IsoMed Infusion Pump

Medtronic Inc. has issued an urgent recall of its Sutureless Connector intrathecal catheter and IsoMed constant-flow infusion pump, which when used together pose a risk of serious complications to patients.

The Class I recall is the strongest such notice the Food and Drug Administration can issue regarding potentially dangerous products. The classification as a Class I recall means the agency has determined there is the potential for death or serious injury from use of the particular device or product.

The complications from the two Medtronic products have been reported only when the two medical devices are used together and no such risks have been identified when the catheter and infusion pump are used individually, the FDA said.

Design Flaw Blamed for Complications

Due to a flaw in the design of the catheter, the device may not properly connect to the IsoMed infusion pump, which is used to supply anti-cancer drugs directly to the liver to help prevent the spread of colon cancer, Medtronic said.

Because of the faulty connection between the catheter and the infusion pump, fluids may leak into surrounding tissues and the proper dose of drugs may not be delivered, leading to withdrawal symptoms in patients, officials said.

The recall involves Medtronic’s Sutureless Connector intrathecal cateter and Revision Kit Models 8709SC, 8731SC, 8578, and 8596SC used along with IsoMed Pump Model 8472, which Medtronic stopped making and marketing in September 2008 but may still be in use, officials said.

One Patient Death, Multiple Injuries Reported

There have been at least 10 reports of serious complications in patients treated with the recalled catheters and infusion pumps, the FDA said. In nine of those cases, the catheters had disconnected from the pumps. A tenth patients developed occlusions, or obstructions in vessels or body cavities, that interfered with the operation of the infusion pump and catheter.

All 10 patients required surgery to fix the problems and one patient died after developing complications following treatment with the two devices, the FDA said.

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