Boston Scientific recalls Maestro 4000 Cardiac Ablation System firmware 5.14 (model numbers M00440000, M0044000D0, etc.) due to reports of unintended radiofrequency energy delivery after foot switch release. Affected users should contact for remedy.
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
Boston Scientific is recalling the Maestro 4000 Cardiac Ablation System with firmware version 5.14 because it can deliver radiofrequency energy unexpectedly after the foot switch is released. This could cause unintended tissue damage during medical procedures. Patients and medical staff using the device should stop using it until a fix is applied.
The device may continue delivering radiofrequency energy even after the foot switch is released. This could cause unintended tissue damage during medical procedures, potentially leading to complications like burns or other injuries.
Medical professionals and patients using the Boston Scientific Maestro 4000 Cardiac Ablation System with firmware version 5.14 are affected. Those performing cardiac procedures with the device are at highest risk.
Check for model numbers M00440000, M0044000D0, M0044000H0, M0044000R0, or M0044000Z0 on the device. The recall applies to all Maestro 4000 Generators used with the optional foot switch.
Reach out to Boston Scientific for instructions on how to address the issue with the device.
Model numbers M00440000, M0044000D0, M0044000H0, M0044000R0, and M0044000Z0.
The recall record does not specify a fix, but users should contact Boston Scientific for instructions.
Check for model numbers M00440000, M0044000D0, M0044000H0, M0044000R0, or M0044000Z0 on the device. The recall applies to all Maestro 4000 Generators used with the optional foot switch.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0202-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0202-2019 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.
