Medtronic Inc. has issued a statement that a catheter and an infusion pump it produces pose serious health risks when used together. This action and potential risk has caused the U.S. Food and Drug Administration to classify the combination as a Class 1 recall.
The two products – the Sutureless Connector intrathecal catheter and the IsoMed constant-flow infusion pump – are still able to be produced because they only pose risks when used together, according to Medtronic spokeswoman Cindy Resman on Monday.
The product recall is about the SC Catheter and Revision Kit Models 8709SC, 8731SC, 8578, and 8596SC, when paired with the IsoMed Pump Model 8472. The particular IsoMed Pump was discontinued in September 2008 “as part of a planned product phase-out,” according to the company.
A disruption in therapy and revision surgery, putting a patient at risk for serious injury or death, are the potential damages, Medtronic said.
Physical signs can include “a drug or cerebrospinal fluid 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,” Medtronic said.
The company voluntarily sent notification letters to doctors in a process that began in August and is ongoing, it said.
Medtronic said patients should seek medical attention immediately if they experience underlying symptoms or drug withdrawal symptoms.