Class IOngoingZ-0109-2026
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
AbbottMNOct 22, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 841–852 of 2,908 recalls
Class IIOngoingZ-0108-2026
MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may nece…
MICROVENTION INC.CAOct 22, 2025
Class IOngoingZ-0105-2026
Boston Scientific Corporation recalls Model Number U228
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0104-2026
Boston Scientific Corporation recalls Model Number U226
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0103-2026
Boston Scientific Corporation recalls Model Number U225 VISIONIST CRT-P EL
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0102-2026
Boston Scientific Corporation recalls Model Number U128
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0101-2026
Boston Scientific Corporation recalls Model Number U125
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0100-2026
Boston Scientific Corporation recalls Model Number S722
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0099-2026
Boston Scientific Corporation recalls Model Number S702
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0098-2026
Boston Scientific Corporation recalls Model Number S701 ALTRUA 2 SR SL Pacemaker
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0097-2026
Boston Scientific Corporation recalls Model Number L131
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025
Class IOngoingZ-0096-2026
Boston Scientific Corporation recalls Model Number L121 ESSENTIO DR EL Pacemaker
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Boston Scientific Corp…MNOct 22, 2025