Medtronic Neuromodulation

16 FDA enforcement actions

16 Total Recalls

0 Class I

16 Class II

0 Class III

Firm Details

Product Types: device
States: MN

All Recalls

Class II: Risk 12/03/2025 device

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Class II: Risk 11/20/2025 device

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
Class II: Risk 04/03/2025 device

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
Class II: Risk 03/04/2025 device

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Class II: Risk 01/09/2025 device

Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Class II: Risk 11/21/2024 device

Software issues were identified in application version 2.x.
Class II: Risk 11/21/2024 device

Software issues were identified in application version 2.x.
Class II: Risk 11/21/2024 device

Software issues were identified in application version 2.x.
Class II: Risk 11/21/2024 device

Software issues were identified in application version 2.x.
Class II: Risk 09/24/2024 device

A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
Class II: Risk 09/18/2024 device

The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Class II: Risk 09/11/2024 device

Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Class II: Risk 08/21/2024 device

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Class II: Risk 06/17/2024 device

A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
Class II: Risk 05/15/2024 device

Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Class II: Risk 05/10/2024 device

Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.