Model Number L110, ESSENTIO SR SL MRI Pacemaker
Reported: October 22, 2025 Initiated: August 20, 2025 #Z-0094-2026
Product Description
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Reason for Recall
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).
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 61,700 units
- Distribution
- Worldwide
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Model Number L110, ESSENTIO SR SL MRI Pacemaker. Recalled by Boston Scientific Corporation. Units affected: 61,700 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Critical. Recall number: Z-0094-2026.
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