Medtronic Neuromodulation Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
UDI/DI 00643169781719
Products Sold
UDI/DI 00643169781719
Medtronic Neuromodulation is recalling Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator due to inability to reprogram one device. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
inability to reprogram one device
Recommended Action
Per FDA guidance
Medtronic issued an URGENT FIELD SAFETY NOTICE to its sole consignee on 03/28/2024 via via an in-person delivery of the customer letter by the Technical Services Representative. The notice explained the issue and risk of resetting the device. Also included were trouble shooting steps and a factory reset to be initiated by Medtronic upon the implanting physicians' authorization.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026