Impella pumps are tiny devices used temporarily used to help support a patient’s heart.
this month about a heart pump associated with reports of 49 deaths and dozens of serious injuries, sharing updated instructions from the device’s maker to doctors on how they should use the device.
Abiomed, the device’s manufacturer, is issuing new instructions to physicians on use of the pump, including how to carefully position the pump’s catheter or use imaging when turning it during procedures.on its website detailing the changes and classified the move as the “most serious type of recall” because of the risk of serious injuries or death if the device is used incorrectly. Even though the FDA referred to a recall, the device will remain on the market. The New York TimesAbiomed in 2022.
not yet known whether the deaths can be attributed directly to the pump. It may be difficult to confirm a direct cause and effect between the device and the injuries.providing guidance on how to use the pump correctly to better avoid perforations to the heart’s wall and incorporated this into its training for doctors. According to FDA spokeswoman Audra Harrison, the company should have submitted this information to the agency within 10 days of the notice, but didn’t do so.
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