Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27454
Brand Name:CN - Percept PC BrainSense B35200
Model:Percept PC BrainSense B35200 - model number - B35200
Affected:
Software version:
Recalling Organisation:Medtronic New Zealand Limited
Unit 16 Mezzanine Level
5 Gloucester Park Road
Onehunga
AUCKLAND
Contact Information:0800 377 807
Manufacturer:Medtronic Inc
Issue:This issue impacts Percept PC patients with cycling enabled. When using the replacement feature to transfer settings from an existing implanted device with cycling enabled to a newly implanted Percept device, cycling is not properly enabled, though it appears to be enabled in the clinician programmer screen and reports. As a result, the patient's stimulation is always on, and battery longevity may be significantly reduced. All Percept PC replacement patients previously implanted with Activa family of devices are at risk for premature battery depletion if they are configured with cycling using the A610 REPLACEMENT workflow.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Healthcare Professional
Date Commenced:17/3/2021
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