PROPONENT dual chamber extended life MRI pacemakers recalled for software update
Boston Scientific is recalling 63,851 PROPONENT DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The PROPONENT DR EL MRI Pacemaker, model L231, is covered by a recall in which software to enhance Safety Architecture is made available.
The software is designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. It applies to the ACCOLADE family of devices, which includes ACCOLADE, PROPONENT, ESSENTIO and ALTRUA 2 dual chamber standard life and extended life pacemakers, and to VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers.
The recall covers 63,851 units carrying GTINs 00802526559143 and 00802526576423, distributed worldwide. The FDA has classified the recall as Class I.
Patients and clinicians should follow Boston Scientific's instructions for obtaining the software update at a device follow-up appointment.
The recalled product
- Product
- Model Number L231, PROPONENT DR EL MRI Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Affected units
- 63,851
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 27 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
Same hazard · software update
See all →- CriticalPacemakers recalled for software update preventing Safety Mode from battery impedance
FDA (Devices) · 2025-10-22
- CriticalACCOLADE dual chamber MRI pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22
- CriticalACCOLADE dual chamber extended life MRI pacemakers recalled for software update
FDA (Devices) · 2025-10-22
- CriticalPROPONENT single chamber pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22
- CriticalVISIONIST MRI resynchronization pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22