Medtronic Percept PC Neurostimulator Recall Due to Software Connection Failure
Medtronic is recalling 12 Percept PC Implantable Neurostimulators because a software anomaly in the A620 Patient Programmer prevents connection to the device.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Neuromodulation is recalling 12 units of the Percept PC Implantable Neurostimulator (INS). This device is used for deep brain stimulation therapy to treat conditions such as Parkinson's disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
The recall is due to a software anomaly identified in the A620 Patient Programmer application. This anomaly results in a failure to connect with the Percept PC device. The affected devices are distributed nationwide in the United States, including in Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, and Washington.
The affected devices are Model Number B35200 with GTIN 00763000253363. Specific serial numbers include NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, and NPI706957H. Patients and healthcare providers should contact Medtronic Neuromodulation for further instructions regarding the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neurostimulator
- Hazard
- Affected units
- 12
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 (14)
- Model Number: B35200
- GTIN: 00763000253363
- Serial Numbers: NPI706941H
- NPI707024H
- NPI707000H
- NPI706992H
- NPI706963H
- NPI706962H
- NPI706987H
- NPI706945H
- NPI706952H
- NPI706954H
- NPI706955H
- NPI706957H
Distribution
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