RecallRadar

FDA Device recall Z-1691-2024

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

On 2024-05-08 the FDA classified a Class II recall of Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator by Medtronic Neuromodulation, citing inability to reprogram one device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1691-2024
ClassificationClass II
Statusongoing
Initiated2024-03-28
Published2024-05-08
Last updated2026-09-13 11:57 UTC
CompanyMedtronic Neuromodulation
Distributionn/a

Product

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

Reason

inability to reprogram one device

Identifiers

code_infoUDI/DI 00643169781719

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1691-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.