Health product recall

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

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

Maestro 4000 Cardiac Ablation System

Lot or serial number
  • 1002180997
  • 412170449
  • 1117170669
  • 419180824
  • 907180934
Model or catalog number
  • M00440000
  • M0044000D0
  • M0044000H0
Companies
Manufacturer
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES