FDA Device recall Z-0085-2026
PROPONENT SR SL (Model L200)
- FDA Device
- Class I
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class I recall of PROPONENT SR SL (Model L200) 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-0085-2026 |
| 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
PROPONENT SR SL (Model L200)
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 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 4…GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 71 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2026%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.