FDA Device recall Z-0094-2026
Model Number L110, ESSENTIO SR SL MRI Pacemaker
- FDA Device
- Class I
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class I recall of Model Number L110, ESSENTIO SR SL MRI Pacemaker by Boston Scientific, citing 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 ACCOL….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0094-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-20 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Reason
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).
Identifiers
| code_info | GTIN 00802526559204, Serial Numbers: 102163, 700197, 700207, 701035, 701546, 702086, 702129, 702195, 702303, 702316, 7…GTIN 00802526559204, Serial Numbers: 102163, 700197, 700207, 701035, 701546, 702086, 702129, 702195, 702303, 702316, 702343, 702530, 702612, 702615, 702619, 702715, 702745, 702802, 702807, 702833, 702840, 702844, 702871, 702872, 702890, 702891, 702898, 702912, 702918, 702925, 702930, 702931, 702966, 702974, 702979, 702991, 702999, 703010, 703035, 703047, 703053, 703058, 703065, 703069, 703090, 703099, 703101, 703122, 703124, 703136, 703142, 703147, 703150, 703152, 703173, 703177, 703191, 703199, 703240, 703241, 703247, 703252, 703261, 703297, 703306, 703326, 703339, 703348, 703353, 703376, 703380, 703417, 703420, 703450, 703452, 703453, 703460, 703510, 703511, 703535, 704093, 704200, 704263, 704341, 704480, 704580, 704656, 704661, 704678, 704679, 704703, 704726, 704755, 704769, 704802, 704812, 704813, 704815, 704817, 704820, 704823, 704839, 704849, 704869, 704872, 704875, 704895, 704898, 704900, 704915, 704926, 704938, 704945, 704956, 704986, 704998, 705007, 705010, 705020, 705038, 70 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-09 · Boston Scientific - LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0094-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.