The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 serious recalls for the Medtronic devices since 2014.
Fridley, Minnesota–based Medtronic halted sales and new device implantations in a Class I recall a year ago following complaints that the internal pump may fail or delay to restart.
Medtronic identified the new problem with pump weld defects this spring while investigating suspected cases of pump thrombosis in three patients, two of whom died after their heart pumps were exchanged.
“Following an inspection of explanted pumps returned to Medtronic, an analysis showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly,” the FDA said today in a recall notice. “Patients with affected devices may present with signs and symptoms that resemble pump thrombosis. If this issue occurs, it may lead to pump malfunction, death, or severe injury (for example: shock with severe organ dysfunction, stroke), or require patients to undergo major surgery to replace the pump.”
The FDA today said the three complaints reported by Medtronic include one death — down from the two previously reported — and two injuries. All three patients had pump exchanges, but Medtronic did not count the death of one patient who had a heart transplant two months after the successful pump exchange and died a month after the transplant, a spokesperson told Medical Design & Outsourcing today.
Medtronic advised physicians to consider removing or exchanging affected pumps on a case-by-case basis due to the risks of the pump exchange procedure.
The recall covers Medtronic HVAD Pump Implant Kit models 1101, 1103, 1104, 1104JP and MCS1705PU. They were distributed from Oct. 11, 2006 to June 3, 2021, the date at which point Medtronic stopped all sales.