Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation
Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that can lead to improper device configuration (cycling settings not copied) and application crashes, representing a risk of harm to patients, but the source text does not report any specific injuries, illnesses, or fatalities.
Plain-English summary
Medtronic Neuromodulation is recalling the A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator. The recall covers software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057. A total of 5,332 downloads are affected. The software was distributed worldwide, including the United States, Puerto Rico, and numerous countries in Europe, Asia, the Middle East, and the Americas.
The recall is due to two specific software issues. First, when using the "replacement" function to copy settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator, the cycling feature is not copied properly. Second, when the Percept PC INS System Event log is full, the A610 software application crashes when it attempts to read the last records in the log.
Clinicians using these specific versions of the A610 Clinician Programmer Application should stop using the affected software and contact Medtronic Neuromodulation for instructions on obtaining a corrected version. Patients with implanted neurostimulators should consult their healthcare provider if they have concerns regarding their device settings or system logs.
The recalled product
- Product
- A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 5,332
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- version 2.0.4584
- 2.0.4594
- 2.0.4605
- and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
Distribution
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