FDA identifies recall of Medtronic blood pump as Class I
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The FDA has identified the recall of Medtronic Perfusion Systems’ extracorporeal blood pumping console as a Class I, the most serious type of recall.
Medtronic recalled the blood pumping console (Bio-Console 560) due to possible electrical failure causing the pump to stop, potentially causing serious injuries or death, according to a press release from the agency.
According to the release, other issues that have been reported include the interface going blank, smoke coming from the device and a burning odor during use.
In cases where the pump stopped or the interface went blank, users operated the pump using a hand crank until the device restarted or was replaced with a backup unit.
The blood pumping console is used during cardiopulmonary bypass to pump and return blood to a patient, and can pump blood for up to 6 hours each time used.
According to the release, nine complaints about this device issue have been reported. The recall includes 93 devices distributed between April 1, 2019 and Feb. 21, 2021.
Three injuries and no deaths were reported.
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