ALTRUA 2 single chamber pacemakers recalled for Safety Mode software update
Boston Scientific is recalling 4,841 ALTRUA 2 SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 ALTRUA 2 SR SL Pacemaker, model S701, 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 4,841 units carrying GTINs 00802526576492 and 00802526559334, 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 S701 ALTRUA 2 SR SL Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Affected units
- 4,841
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 00802526576492
- Serial numbers: 705372. GTIN 00802526559334. Serial numbers: 100002
- 100003
- 100004
- 100005
- 100007
- 100008
- 100009
- 100010
- 100011
- 100012
- 100013
- 100014
- 100015
- 100016
- 100017
- 100018
- 100019
- 100020
- 100021
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 →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- 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
Same hazard · software update
See all →- CriticalPacemakers recalled for software update preventing Safety Mode from battery impedance
FDA (Devices) · 2025-10-22
- CriticalALTRUA 2 dual chamber extended life pacemakers recalled for 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
Similar recalls
- CriticalALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk
FDA (Devices) · 2025-01-22
- HighBoston Scientific Recalls ALTRUA 2 SR Pacemakers Due to Sensor Issues
FDA (Devices) · 2018-01-24
- HighBoston Scientific Recalls ALTRUA 2 DR Pacemakers Due to Sensor Issues
FDA (Devices) · 2018-01-24
- HighAltrua 2 Pacemakers at Risk from Hydrogen-Induced Battery Failure
FDA (Devices) · 2021-07-14
- HighBoston Scientific Recalls ALTRUA 2 EL DR Pacemakers Due to Sensor Issues
FDA (Devices) · 2018-01-24
- SevereACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation
FDA (Devices) · 2025-01-22