Medtronic Percept RC Implantable Neurostimulators Unable to Communicate with Programmer
Medtronic Percept RC implantable neurostimulators (Model B35300) may fail to communicate with the A610 DBS Clinician Programmer, displaying an 'Invalid Device' message. This prevents clinicians from adjusting therapy.
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: FDA Class II medical device with functional defect preventing programmer communication. No illnesses, injuries, or hospitalizations reported. Theoretical risk-of-harm scenario without reported adverse events scores at maximum 3 per the rubric.
Plain-English summary
Medtronic Neuromodulation is recalling Percept RC Implantable Neurostimulators, Model B35300. A limited number of these devices will not communicate with the A610 DBS Clinician Programmer Application upon use. When communication fails, an 'Invalid Device' message appears.
The recall involves 39 units distributed internationally to Germany, the United Kingdom, and Israel. The affected devices are identified by specific serial numbers and product codes documented in the official FDA recall notice.
The inability to communicate between the implanted neurostimulator and the programmer prevents clinicians from adjusting therapy settings and monitoring the device. This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations.
The recalled product
- Product
- Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 39
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 (20)
- GTIN 00763000813468
- Serial Numbers: NND504236H
- NND504252H
- GTIN 00763000813475
- Serial Numbers: NND504165H
- NND504169H
- NND504174H
- NND504181H
- NND504208H
- NND504212H
- NND504215H
- NND504216H
- NND504217H
- NND504218H
- NND504221H
- NND504222H
- NND504223H
- NND504224H
- NND504229H
- NND504230H
Distribution
Distribution scope not specified by the agency.
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