FDA Device recall Z-0091-2026
Model Number L231, PROPONENT DR EL 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 L231, PROPONENT DR EL 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-0091-2026 |
| 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 L231, PROPONENT DR EL 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 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 9…GTIN 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282, 100283, 100288, 100289, 100292, 100293, 100294, 100296, 100299, 100300, 100302, 100305, 10 |
|---|
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-0091-2026%22
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