Boston Scientific Recalls Maestro 4000 Cardiac Ablation Systems Due to RF Energy Issue
Boston Scientific is recalling Maestro 4000 Cardiac Ablation Systems because radiofrequency energy may continue to deliver after the foot switch is released.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a significant injury risk due to unintended radiofrequency energy delivery, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Boston Scientific Corporation is recalling 793 units of the Maestro 4000 Cardiac Ablation System, Firmware Version 5.14. The affected model numbers are M00440000, M0044000D0, M0044000H0, M0044000R0, and M0044000Z0. The recall applies to all Maestro 4000 Generators used with the optional foot switch.
The recall was initiated due to reports of unintended continuation of radiofrequency (RF) energy delivery from the cardiac ablation system after the foot switch has been released. This defect poses a risk of unintended energy delivery during medical procedures.
The affected devices were distributed in the United States and numerous foreign countries, including Canada, Germany, France, and Japan. Healthcare facilities and users of these devices should contact Boston Scientific for instructions on how to address the issue.
The recalled product
- Product
- Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 793
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 (1)
- All Maestro 4000 Generators used with the optional foot switch.
Distribution
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