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205 results
FDA · FDA event 99304
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Posted Jul 28, 2026
FDA · FDA event 99192
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Posted Jul 10, 2026
FDA · FDA event 98700
Due to packaging discrepancy with incorrect product size mixed up.
Posted Jul 8, 2026
FDA · FDA event 99207
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23.…
Posted Jul 8, 2026
FDA · FDA event 99034
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an…
Posted Jun 30, 2026
FDA · FDA event 99078
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Posted Jun 29, 2026
FDA · FDA event 99063
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Posted Jun 25, 2026
FDA · FDA event 99073
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Posted Jun 24, 2026
FDA · FDA event 98968
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for…
Posted Jun 24, 2026
FDA · FDA event 98888
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of…
Posted Jun 23, 2026