Medtronic Inc., the world’s largest medical technology company, has recalled a specific class of catheters that have been deemed incompatible with the IsoMed constant-flow infusion pump. Medtronic has notified physicians of this incompatibility.
The U.S. Food and Drug Administration categorized this as a Class 1 recall–because of the possibility of serious injury or death.
According to a Medtronic news release, the affected products include the following models: SC [Sutureless Connector]Catheter and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the IsoMed Pump Model 8472, which is no longer manufactured and marketed. Medtronic indicated that it took the IsoMed infusion pumps out of production in September 2008 as part of a previously determined product phase-out.
Medtronic states that other types of intrathecal catheters and intravascular catheters for delivery of chemotherapy are unaffected by the incompatibility issue.
To date, Medtronic has received ten reports worldwide of improper connections of an SC catheter to an IsoMed pump, which required medical intervention to correct the condition.
The Medtronic news release states that “the clinical manifestations of an incomplete connection of an SC catheter to an IsoMed pump may include, but are not limited to, drug or cerebrospinal fluid (CSF) leakage into surrounding tissue, resulting in tissue damage, loss of or change in therapy, a return of underlying symptoms, drug withdrawal symptoms, a severe (‘spinal’) headache, and/or a clinically significant or fatal drug underdose.”
There have been other recalls involving Medtronic medical devices. In May 2009, approximately 21,000 Medtronic pacemakers were recalled due to a high risk of failure caused by the separation of wires that connect the electronic circuit to other parts of the pacemaker, in what the FDA also classified as a Class 1 recall.
More recently, Forbes and the Wall Street Journal reported in mid-September that Medtronic started recalling some LifePak CR defibrillators manufactured by a company subdivision about a year ago because humidity may cause them to malfunction. The FDA notification also designated this as a Class 1 recall.
If you–or a loved one–have sustained an injury from a defective Medtronic pacemaker, you may have a legal claim against the manufacturer of the device. Do not hesitate to contact the lawyers at the Law Offices of Richard J. Serpe, P.C. for a no-obligation consultation, Toll Free 877-544-5323.