Medtronic, the world's largest manufacturer of medical devices for the heart, has joined the FDA in a recall of two medication pumps. The recall follows an urgent notice sent to healthcare providers about an increased risk that the pump will fail.
The pumps have a 2.4 percent failure rate when used with specifically approved medications. When used with other medications the failure rate rises to seven percent. When the devices fail, it means that medicine is no longer being delivered to the patient properly. This can be hard to detect at first, so some patients have become ill again after a long period of time without medication. The FDA says that death is also a risk.
The company says that so far no deaths have been linked to the pump failure, which is why it has not been taken off of the market at this time. The internal investigation into the issues with the pump is focusing on possible motor gear corrosion, according to company sources.
A recent FDA letter about the device indicated that there have been 567 complaints about the pump malfunctioning. Both the company and the FDA say that the concern is primarily for patients using the pump to administer drugs that were not specifically approved for use with the device.
People who are injured by defective medical equipment are entitled to seek compensation from the device maker. Companies should be held responsible for marketing defective products, particularly in cases where the defect was known. In this case, the risk of corrosion was identified initially 2007.
Source: Bloomberg, "Medtronic Recalls Drug Pumps After Infusion Failures," Michelle Fay Cortez, Dec. 21, 2012.