Z-0780-2024 Class II Ongoing
FDA device recall Z-0780-2024 was initiated by Medtronic Neuromodulation on Dec 19, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1 tablet.
Recall details
- Product Type
- Devices
- Report Date
- Jan 31, 2024
- Initiation Date
- Dec 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 tablet
Product description
Model A710 Intellis Clinician Programmer Application, version 2.0.97
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.
Distribution pattern
Germany
Code information
UDI/DI 00763000520076, S/N: NPL1000519
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0780-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026