Medtronic Heart Pump Recall Deemed Life-Threatening by FDAby
One patient death may have been related to the product flaw
Doctors and patients were previously notified of the problem
Flaws with a heart device that Medtronic Plc bought last month as part of a $1 billion deal have been deemed potentially life-threatening by U.S. regulators.
The device, called the HVAD System, takes over for a failing heart. One patient may have died because of a flaw where moisture can penetrate the mechanical pump through loose power or data connectors, said Chris Garland, a spokesman for the company. Medtronic acquired the device with its purchase last month of HeartWare International.
Doctors and patients were first notified about the issue in May and June, with instructions to closely monitor the HVAD System for loose connections, the company said in a statement Friday. The U.S. Food and Drug Administration has since classified the issue a Class 1 recall, meaning the problem is potentially life-threatening. Recall designations are used to classify an issue’s severity, and doesn’t mean that the devices necessarily need to be removed from patients and replaced.
Almost all 8,799 patients who could be affected have been notified, and 308 controllers have been replaced, the company said. Last month, the company recalled the pump kits that were in hospital inventories because they were vulnerable to electrical faults and connection failures from exposure to moisture. The company has recovered 323 of those 350 at-risk kits.
Shares of Medtronic, which is based in Dublin and run from the U.S., were up less than 1 percent to $86.11 at 10:41 a.m. in New York.