Vanta AdaptiveStimRecalls & reported problems across all models

We found 3 models of Vanta AdaptiveStim by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,380 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2021 and Sep 30, 2026 — classified as 579 injuries, 801 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (205 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Vanta AdaptiveStim recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 21, 2024Open, Classified

   Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

   Z-0132-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Jun 6, 2023Open, Classified

   A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

   Z-2036-2023 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 30, 2022Open, Classified

   The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

   Z-1123-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Vanta AdaptiveStim problems

Vanta AdaptiveStim models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vanta™ AdaptiveStim™ 977006

  Stimulator, spinal-cord, totally implanted for pain relief
  3 recalls1,151 reports
• Vanta™ AdaptiveStim™ 977006

  Stimulator, spinal-cord, totally implanted for pain relief
  1 recall94 reports
• Vanta™ AdaptiveStim™ 977006

  Stimulator, spinal-cord, totally implanted for pain relief
  135 reports

Recent Vanta AdaptiveStim adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock; Pain

  MAUDE report 50951954 ↗
• InjurySep 30, 2026Migration or Expulsion of Device

  Information was received from a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (INS). They reported that the patient's paddle lead migrated by one vertebral body and this was revised this morning. They kept the same paddle as the first implant and just adjusted the paddle lead today. Revision was completed successful. The follow up appointment is (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951797 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Energy Output Problem

  Information was received from Patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient (Pt) reported that when the intensity was increased to 12.6 from 11.4 in Group A, they could not feel stimulation on the right side but could feel it on the left side. Pt stated they could not get it to work on both sides. Pt also stated that they tried switching to Group B and increased the intensity to 9.5 from 9.4 and they felt the stimulation in their back and down their legs, although the intensity was set at around 8. Pt noted that Group C did not work at all at an intensity of 4 and stated that they were unable to change it. Pt also stated that no error message was received. Pt also noted they were not using Group B that much and mostly used Group A. Patient mentioned they were in so much pain. Agent reviewed information. The pt was redirected to their HCP.

  Patient problems: Pain

  MAUDE report 50947142 ↗
• InjurySep 29, 2026Electromagnetic Interference

  It was reported that patient had increased pain and numbing in upper extremities after a lumbar MRI. They reported that the pain increased by turning on the implantable neurostimulator (INS). Patient met with manufacturer representative (rep) for reprogramming. Issue is ongoing. The relationship of the event to the device or therapy is causal but it is not related to the implant procedure.

  Patient problems: Numbness; Pain

  MAUDE report 50931858 ↗
• InjurySep 28, 2026Migration or Expulsion of Device

  Patient problems: Discomfort

  MAUDE report 50916341 ↗
• InjurySep 28, 2026Break; Migration or Expulsion of Device; Impedance Problem

  It was reported that during implantable neurostimulator (INS) relocation and replacement, the existing leads migrated downward by two vertebral levels after being pulled through the skin to obtain additional slack. X-ray imaging performed during the procedure ide ntified the lead migration. One existing lead had an electrode with no connection when inserted into the new INS. Both existing leads were removed and replaced with new leads, and the existing INS was replaced. The device revision was completed successfully, and the issue was resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915680 ↗
• InjurySep 28, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915615 ↗
• InjurySep 25, 2026Overheating of Device; Insufficient Device Problem Information

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator. The reason for call was rep states the patient is complaining of heat, tingling, and burning at the pocket site of their generator over the past 2-3 months. Representative stated this happens 2-3 times per week and the patient turns the stimulation off and it is better for 20 minutes and then when they turn it back on, it doesn't happen for a few days. Representative asked if it sounds like it's hitting a nerve and if the patient has had any falls or car accidents and if they turn the stimulation up or down and they said no. Representative also asked if there is anything different at those times like their activity or pressing against anything and patient said no, nothing had changed. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue. Agent advised having the patient keep a diary of when they experience this sensation prior to meeting with someone.

  Patient problems: Burning Sensation; Paresthesia

  MAUDE report 50900360 ↗
• InjurySep 25, 2026Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient experienced new urinary incontinence, a shocking sensation in the left leg, and potential lead dislodgement. The patient was evaluated in the emergency department and was currently in the emergency department. The healthcare provider (HCP) ordered magnetic resonance imaging for diagnostic evaluation. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Electric Shock; Incontinence

  MAUDE report 50897923 ↗
• InjurySep 25, 2026High impedance

  Information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neu rostimulator (INS). It was reported that high impedances were observed on the day of surgery. Impedances were at 40,000 for all electrodes 0-15. Additional information was received from a manufacturer representative (rep). It was reported that the lead was not removed. The patient was only consented and consented for a battery replacement. The battery had reached End of Service (EOS). The lead remains implanted and the surgeon stated they need insurance approval for a lead revision. It was unknown if there were any external/environmental/patient factors that may have caused or contributed to the high impedances. The patient was asked if they had any falls or anything happened that may have caused the high impedances and the patient stated there were no falls or anything. The rep stated the battery will be shipped out and the lead remains implanted and will be returned after the lead revision.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896323 ↗
• InjurySep 25, 2026Failure to Deliver Energy

  Information was received from patient regarding an external device. The reason for the call was that the patient reported they were unable to connect to their implantable neurostimulator (INS) , and the screen would only show "Connecting." During the call, the agent instructed the patient to reset the communicator and assisted them in connecting it to their INS, but the screen became stuck on the "Connecting" screen again and it wont even connect. The agent then instructed the patient to reset both the handset and the communicator. After that, the patient attempted to connect to their Mystim app and was able to view the therapy screen. The patient stated that the therapy was on, but they could not feel the stimulation. The agent then instructed the patient to make adjustments in the settings and redirected them to their healthcare provider (HCP)  if further assistance was needed. Patient called back and repeated previously documented  information. Patient reported issue persisted with handset stuck on "Connecting screen" even after restarting both handset and communicator. Patient stated they could not continue living with the need to repeat connection steps every time they attempt

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50894783 ↗
• MalfunctionSep 24, 2026Battery Problem

  Information was received from a patient regarding an implantable neurostimulator (INS). The reason for call was caller reported seeing ERI Service Code 201 message on their handset since yesterday. Agent reviewed meaning of message. Caller stated they just got the implant in April and thought it would last for 3 years. The patient was redirected to their healthcare provider (HCP) to further address next steps.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886160 ↗
• InjurySep 24, 2026Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Data Problem

  Patient problems: Device Overstimulation of Tissue; Electric Shock; Pain

  MAUDE report 50885514 ↗
• InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation

  Information was received from an HCP regarding an implantable neurostimulator.  Caller stated that the patient has not been using the device because they were getting shocks when it was working. Caller did not know the exact date when the shocking started, but the patient said it had been a while ago.

  Patient problems: Electric Shock

  MAUDE report 50885274 ↗
• InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation

  The reason for call was patient mentioned that they needed assistance turning the therapy off. Patient mentioned that whenever they would lay down, they would get electric impulses. Patient mentioned that they might need to have exams and might lay on their back, so Patient needed to turn the Therapy off. Agent had Patient connect to MyStim app and mentioned that they were not able to connect. Agent had Patient reset the communicator, and connect to MyStimPC. Agent walked Patient thru turning the Therapy off, Patient confirmed Therapy was off. Agent walked Patient through on how to enter into an MRI mode.

  Patient problems: Electric Shock

  MAUDE report 50883922 ↗

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