patient-safety
Every record this desk has filed under patient-safety, 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-recallsheart-pumpabiomedhospitals
A customer found a bag of concentrated potassium chloride inside a wrap labeled as saline, and Otsuka ICU Medical has recalled saline lot 1042188, distributed in the United States from December 30, 2025 to June 22, 2026; it is the third recall this desk found since February 2025 in which an ICU Medical-brand potassium chloride bag sat in a wrap that did not match it.
Otsuka ICU Medical LLC is recalling one lot of 0.9% Sodium Chloride Injection, USP, 100 mL (NDC 0990-7984-23, lot 1042188, expiring 31 October 2027) after a customer found a bag of highly concentrated 10 mEq potassium chloride injection (NDC 0990-7074-26, lot 1035181) inside the saline's overwrap. The lot was manufactured November 13, 2025 and distributed in the United States from December 30, 2025 through June 22, 2026. The company's announcement, dated September 17 and posted by FDA on September 21, says inadvertent injection of concentrated potassium chloride can cause harm up to death from cardiac arrest, and that the company has received no reports of adverse events. Customers, including distributors, are asked to check their inventory, quarantine the lot and stop using it. This desk found two earlier recalls, in February and October 2025, in which ICU Medical-brand potassium chloride bags sat in wraps that did not match them; FDA classified both Class I, its most serious category. FDA's enforcement data, last updated September 16, held no classification for the new recall when this desk looked.
Also filed underfdadrug-recallhospitalsiv-fluidsmedication-errors
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