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Terminated

Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

FDA Recall Z-0612-2021 · Posted None

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeMHY
Date Initiated2020-11-19
Date Terminated2023-04-03
Product Quantity12 devices

Reason for Recall

A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

Firm Action

Beginning November 19, 2020 accounts impacted by this issue were verbally notified to quarantine affected product. Beginning November 25, 2020 a recall notification letter and retrieval instructions titled "URGENT: MEDICAL DEVICE RECALL A620 Patient Programmer issue with specific Percept" PC Neurostimulators" was hand delivered to impacted accounts by Medtronic Representatives.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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