Boston Scientific recalls ALTR:UA 2 DR Pacemaker model S702 due to intermittent over-sensing of Minute Ventilation sensor signal. This may cause incorrect pacing signals. No remedy specified in recall notice.
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 DR pacemakers with model number S702 because they may sense ventilation signals incorrectly, potentially causing improper pacing. This could lead to health issues for users with pacemakers.
The pacemaker may incorrectly interpret ventilation signals, leading to improper pacing. This could cause the device to malfunction and affect heart rhythm control.
People with ALTRUA 2 DR pacemakers (model S702) who have been implanted with the device. Those with cardiac conditions requiring pacemakers are most at risk.
Check if your pacemaker model is S702. The device is part of Boston Scientific's ALTRUA 2 DR series. This recall applies to specific pacemaker models sold under this title.
Look for the model number on your pacemaker's label or documentation to confirm if it is S702.
The recall notice does not specify any remedy or fix for this issue.
Check if your pacemaker model is S702, as this specific model is part of the recalled ALTRUA 2 DR series.
The recall notice does not provide specific action steps for affected users.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0363-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0363-2018 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.
