Z-1691-2024Class II

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

Name: Z-1691-2024 Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Creator: Medtronic Neuromodulation
Published: 2024-03-28
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2024-03-28 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator on 2024-03-28. FDA classified it as Class II and gives the reason as "inability to reprogram one device". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1691-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-28
Posted: 2024-04-26
Recalling firm: Medtronic Neuromodulation
Product: Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: inability to reprogram one device
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1 unit
Distribution: International distribution in the country of UK.
Product codes and lots: UDI/DI 00643169781719

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1691-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1691-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-26

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)