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414 results
FDA · FDA event 99080
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as…
Posted Jun 17, 2026
FDA · FDA event 98963
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Posted Jun 11, 2026
FDA · FDA event 98872
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Posted Jun 5, 2026
FDA · FDA event 98929
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Posted Jun 3, 2026
FDA · FDA event 98699
Potential for the Cassette Loading Lever to break.
Posted May 29, 2026
FDA · FDA event 98945
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically,…
Posted May 29, 2026
FDA · FDA event 98750
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of…
Posted May 14, 2026
FDA · FDA event 98639
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay"…
Posted May 11, 2026
FDA · FDA event 98554
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below…
Posted May 1, 2026
FDA · FDA event 98707
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Posted Apr 29, 2026