ALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
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: This recall is classified as FDA Class I, which represents the highest risk classification for medical devices. The potential for unexpected device shutdown in a life-supporting pacemaker presents a serious health threat regardless of whether adverse events have been currently reported.
Plain-English summary
The ALTRUA 2 DR Pacemaker (Models S702 and S722) is subject to a recall due to a potential safety issue affecting certain units manufactured before September 2018. The recalled devices may initiate Safety Mode unexpectedly during telemetry transmissions or other normal, higher-power operations. This malfunction is caused by latent high battery impedance within the affected pacemakers.
Safety Mode in a pacemaker is a protective response. Unintended activation during normal operation could impair the device's ability to pace the heart, potentially creating serious health risks for patients who depend on their devices.
The recall affects approximately 156,329 units globally, with 59,937 units distributed in the United States (including Puerto Rico and US Virgin Islands) and 96,792 units distributed internationally to Guam and the Northern Mariana Islands. Specific serial numbers affected are listed on the FDA's official recall notice.
Patients with affected devices should contact their healthcare provider for guidance regarding their specific situation.
The recalled product
- Product
- ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
- unintended-safety-mode
- battery-impedance
- pacemaker-malfunction
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 (8)
- S702 - UDI-DI: 00802526559358
- 00802526576508
- 00802526577000
- 00802526578106
- S722 - UDI-DI: 00802526559372
- 00802526576515
- 00802526578113
- 00802526593239
Distribution
Distributed nationwide across the United States.
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