The FDA puts its highest-risk label on a recall of programmable infusion pumps made by Codman &Shurtleff Inc., a division of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics.
Codman’s implanted MedStream pumps were recalled over a potential defect in a component that measures the contents of the pump reservoir. According to the company’s estimates around 1% of the pumps are likely affected, and new shipments were halted while Codman resolves the issue.
"The malfunction in the Fill Level Sensor may cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or too late," according to the FDA notice. "A late sounding alarm could result in a pump not being refilled in time, which could result in the under delivery or discontinuation of medications like Baclofen. This could result in serious medical illness or death."
Codman issued a notice to customers early last month, informing them of the potential issue and asking that they evaluate the infusion pumps for each patient during routine sessions or sooner if patients are experiencing problems.
The company stopped short of recommending that patients switch pumps.