Loading MedWatcher information…
100 results
FDA · FDA event 97032
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Posted Jun 27, 2025
FDA · FDA event 96945
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone…
Posted Jun 24, 2025
FDA · FDA event 96743
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to…
Posted Jun 16, 2025
FDA · FDA event 96774
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to…
Posted Jun 9, 2025
FDA · FDA event 96796
Unreleased software versions were installed on distributed devices without verification or validation.
Posted Jun 6, 2025
FDA · FDA event 96684
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts…
Posted Jun 4, 2025
FDA · FDA event 96801
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life…
Posted May 30, 2025
FDA · FDA event 96721
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Posted May 20, 2025
FDA · FDA event 96611
A cybersecurity vulnerability was discovered through internal testing.
Posted May 9, 2025
FDA · FDA event 96620
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Posted May 7, 2025