Z-0780-2024Class II

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Name: Z-0780-2024 Model A710 Intellis Clinician Programmer Application, version 2.0.97
Creator: Medtronic Neuromodulation
Published: 2023-12-19
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2023-12-19 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Model A710 Intellis Clinician Programmer Application, version 2.0.97 on 2023-12-19. FDA classified it as Class II and gives the reason as "Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0780-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-19
Posted: 2024-01-22
Recalling firm: Medtronic Neuromodulation
Product: Model A710 Intellis Clinician Programmer Application, version 2.0.97
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
FDA root cause: Under Investigation by firm
Action: OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.
Quantity in commerce: 1 tablet
Distribution: Germany
Product codes and lots: UDI/DI 00763000520076, S/N: NPL1000519

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0780-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0780-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-22

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)