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414 results
FDA · FDA event 97997
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Posted Feb 2, 2026
FDA · FDA event 97871
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid…
Posted Jan 29, 2026
FDA · FDA event 98167
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature…
Posted Jan 16, 2026
FDA · FDA event 98128
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the…
Posted Jan 16, 2026
FDA · FDA event 98129
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback…
Posted Jan 15, 2026
FDA · FDA event 98049
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Posted Jan 14, 2026
FDA · FDA event 98106
Emphasizing instructions for LVP duration programming located in the IFU.
Posted Jan 12, 2026
FDA · FDA event 98009
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Posted Dec 16, 2025
FDA · FDA event 97971
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Posted Dec 9, 2025
FDA · FDA event 97941
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Posted Dec 3, 2025