Altrua 2 Pacemakers at Risk from Hydrogen-Induced Battery Failure
Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.
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: FDA Class II medical device recall affecting a life-critical cardiac device. The hazard represents a theoretical risk of device malfunction (accelerated battery depletion) with no reported illnesses or injuries in the source, per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling certain Altrua 2 pacemaker models: S701, S702, and S722. A total of 2,952 units have been distributed worldwide. These pacemakers contain a latent defect involving hydrogen gas release within the device.
The hydrogen may gradually compromise the low-voltage capacitor, causing electrical damage over time. This electrical damage results in accelerated depletion of the device's battery and faster progression of the displayed battery status indicators.
Patients with affected pacemakers should contact their healthcare provider or Boston Scientific for further guidance regarding their device.
The recalled product
- Product
- Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 2,952
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)
- a) S701
- Serial Numbers: 100005
- 100011
- 100012
- 100015
- 100017
- 100021
- 100022
- 100028
- 100032
- 100034
- 100037
- 100053
- 100055
- 100059
- 100060
- 100068
- 100075
- 100079
- 100082
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 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.
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