Reported Oct 31, 2018 · Ongoing
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0,…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14
- Model Numbers
M00440000M0044000D0M0044000H0M0044000R0M0044000Z0
- Lot codes and dates
- All Maestro 4000 Generators used with the optional foot switch.
- Amount recalled
- 793
Where it was sold
Why it was recalled
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
This product could cause temporary or reversible health problems — stop using it.
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