Boston Scientific recalls ALTR:UA 2 SR pacemakers (model S701) due to intermittent over-sensing of Minute Ventilation sensor signals, which may cause improper heart rhythm management.
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Boston Scientific is recalling ALTRUA 2 SR pacemakers (model S701) because they may intermittently misread the Minute Ventilation sensor signal, potentially causing improper heart rhythm management. This could lead to unintended heart rhythm changes if the device malfunctions.
The pacemaker may intermittently misread the Minute Ventilation sensor signal, causing it to send incorrect heart rhythm commands. This could lead to unintended heart rhythm changes if the device malfunctions.
Owners of the ALTRUA 2 SR pacemaker (model S701) are affected. Patients with pacemakers or cardiac resynchronization therapy devices are most at risk.
Check for the ALTRUA 2 SR pacemaker model S701. This device was sold by Boston Scientific Corporation.
Identify if your pacemaker is model S701 by checking the device label.
The recall is for potential misreading of the Minute Ventilation sensor signal, which could cause unintended heart rhythm changes. However, the hazard level is low risk as the device may not malfunction in all cases.
Check if your pacemaker is model S701. If so, contact Boston Scientific for further instructions.
Look for the model number S701 on the device label. This specific model was recalled by Boston Scientific.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0362-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0362-2018 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
