MAESTRO 4000 Cardiac Ablation System (2018-06-20)

Starting date:

June 20, 2018

Posting date:

July 13, 2018

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-67218

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  Reason
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  Affected products

Affected products

MAESTRO 4000 Cardiac Ablation System

Reason

Boston Scientific has received reports of unintended continuation of radiofrequency (RF) energy delivery from the Maestro 4000 Cardiac Ablation System after the foot switch has been released. Boston Scientific has confirmed the Maestro 4000 is meeting performance expectations and that this rare behavior can be resolved with existing instructions within the operator's manual. Unintended RF energy delivery can be detected if, after releasing the foot switch, RF parameters continue displaying on the control panel and the system continues emitting an audible tone. If this behavior occurs after releasing the foot switch, follow instructions within the manual to stop RF delivery by pressing the RF Power Control Button on either the System Controller (Generator) or System Remote Control (Remote).

Affected products