Maestro 4000 Cardiac Ablation System (2020-01-13)

Starting date:

January 13, 2020

Posting date:

December 24, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74627

Last updated:
2020-12-24

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  Reason
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  Affected products

Affected Products 

Maestro 4000 Cardiac Ablation System

Reason

Potential for unintended continuation of radiofrequency energy delivery from Maestro 4000 after releasing the foot switch. Only systems using the optional foot switch accessory are susceptible to this unintended rf delivery behavior. Boston is beginning the process of upgrading the firmware.

Affected products