FDA hits Medtronic sutureless catheter with Class I recall
Design flaw caused leakage, other problems in 10 patients when implant was used with Medtronic IsoMed infusion pumps.

-MassDevice

09/16/2009 - The U.S. Food and Drug Administration has classified a letter intended to correct a labeling error made by Medtronic Inc. with its Sutureless Connector intrathecal catheters as a Class I recall, the agency's most severe level of call-back.

Last month, Fridley, Minn.-based Medtronic voluntarily began sending letters to physicians (PDF) informing them that the SC catheters were not compatible with its IsoMed constant-flow infusion pumps. The company took action after receiving reports earlier this summer of serious complications with 10 patients receiving the implants. In nine of the cases, the catheters had disconnected from the pumps; the 10th patient suffered from occlusions interfering with proper operation of the device.

All 10 patients required surgery to correct the problem and one person died two days following the procedure, although the company said it is not sure whether the death was directly related to use of the device.

The FDA issues Class I recalls when there is potential for serious injury or death from use of a particular device or product. Other Medtronic catheters are not affected by the recall and the SC catheters also are compatible with other Medtronic infusion pumps.

According to the company, a design flaw with the SC catheter prevents the device from completely connecting to the IsoMed pump, approved by the FDA to supply anti-cancer drugs directly to the liver to help prevent the spread of colon cancer. Risks include fluids leaking into surrounding tissues, drug under-dosing and withdrawal symptoms.

Doctors who have implanted the SC catheter with IsoMed pumps are being told to use their Clinical judgment to determine if corrective procedures are needed. They also are being warned not to try to reconnect the device because of the risk of potential damage to the implant.

If you or a loved one have had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation.