October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L221 PROPONENT DR EL Pacemaker
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L211 PROPONENT DR SL MRI Pacemaker
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L210 PROPONENT SR SL Pacemaker
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT DR SL (Model L201)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT SR SL (Model L200)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR EL MRI (Model L331)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR EL (Model L321)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR SL MRI (Model L311)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE SR SL MRI (Model L310)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR SL (Model L301)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE SR SL (Model L300)
Hazard: 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 ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.