heart-pump
Every record this desk has filed under heart-pump, newest first, each with the number of sources it can still show you.
The FDA has put Abiomed's removal of every Automated Impella Controller, the console that runs the Impella heart pump, in its most serious recall class; Abiomed has reported 37 serious injuries and three deaths associated with a failing sensor part, and hospitals may keep using the controllers until that part is replaced.
On September 24 the Food and Drug Administration said it had classified Abiomed's removal of its Automated Impella Controllers, the consoles that run the Impella heart pump, as a Class I recall, the most serious type. A part in the controller's purge pressure sensor assembly, the purge flag, can fail, so the controller stops recognizing the purge disc and raises a 'Purge Disc Disconnected' or 'Purge Disc not Detected' alarm. Clearing it can mean swapping the controller, which can delay the start of support or briefly interrupt it. As of August 17, Abiomed had reported 37 serious injuries and three deaths associated with the issue. Every controller worldwide is in scope, and FDA's three recall database entries together list 10,754 units, 7,005 of them in the United States. Hospitals may keep using them until Abiomed services them, and are told to switch to a backup controller if the alarm will not clear. Abiomed began the recall with letters on August 12. A separate FDA early alert, current as of September 23, lists 237 controller serial numbers needing hardware, firmware or software updates; no serious injuries or deaths were reported for that issue as of September 8.
Also filed underfdamedical-devicesdevice-recallsabiomedhospitalspatient-safety
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