Boston Scientific Recalls ALTRUA 2 DR Pacemakers Due to Sensor Issues
Boston Scientific is recalling ALTRUA 2 DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or death fall into the 'High' category, representing a risk of harm where injury has not yet been reported or is theoretical.
Plain-English summary
Boston Scientific Corporation is recalling ALTRUA 2 DR Pacemakers (Model S702). The recall is being conducted because the company has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal in certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems.
The affected devices were distributed in all 50 U.S. states, Puerto Rico, and worldwide. The source text does not specify the total number of units affected or the specific dates of distribution.
Consumers with this device should contact their healthcare provider or Boston Scientific for instructions on how to proceed. The source text does not provide specific instructions for consumers beyond the general recall notice.
The recalled product
- Product
- ALTRUA 2 DR Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
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 (1)
- Model S702
Distribution
Part of a larger recall action
This product is one of 24 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 24 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- 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
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · sensor malfunction
See all →- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- SevereiLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings
FDA (Devices) · 2026-05-06
- SevereAbiomed Impella RP with SmartAssist recalled as Class I
FDA (Devices) · 2026-03-11
- SevereAbiomed Impella RP recalled as Class I over sensor malfunction risk
FDA (Devices) · 2026-03-11
Similar recalls
- CriticalALTRUA 2 dual chamber pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22
- CriticalALTRUA 2 single chamber pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22
- CriticalALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk
FDA (Devices) · 2025-01-22
- CriticalALTRUA 2 dual chamber extended life pacemakers recalled for software update
FDA (Devices) · 2025-10-22
- HighAltrua 2 Pacemakers at Risk from Hydrogen-Induced Battery Failure
FDA (Devices) · 2021-07-14
- ModerateBoston Scientific MRI PROPONENT SR Pacemaker Recall for Incorrect Literature Labeling
FDA (Devices) · 2016-01-20