InterStim XRecalls & reported problems across all models

We found 2 models of InterStim X by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 7,752 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2022 and Sep 30, 2026 — classified as 3,371 injuries, 4,381 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1,634 reports).

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

Most reported InterStim X problems

InterStim X models

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

• InterStim™ X 97800

  Implanted electrical device intended for treatment of fecal incontinence
  5,930 reports
• InterStim™ X 97800

  Stimulator, electrical, implantable, for incontinence
  1,822 reports

Recent InterStim X adverse event reports

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

• MalfunctionSep 30, 2026Premature Discharge of Battery

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that they had some surgery up at Cleveland Clinic and they were going to turn off the MRI turnoffs that stimulated for the MRI, but it wouldn't work at all. The patient said earlier this year they had an MRI of their prostate, and it worked fine, but between May and September 22nd when they had the surgery, the battery died in the device. Patient asked why the battery would have expired so soon. Agent reviewed battery longevity information with the patient. Patient mentioned that their previous implant always used up and even in the old one that was not MRI compatible, they always had to use about 4.2 source of stimulation. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950306 ↗
• InjurySep 30, 2026Break; Failure to Deliver Energy; Unstable; Low impedance

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950091 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Migration or Expulsion of Device

  Patient problems: Urinary Incontinence

  MAUDE report 50948804 ↗
• InjurySep 30, 2026Electromagnetic Compatibility Problem

  Patient problems: Incontinence; Insufficient Information

  MAUDE report 50948716 ↗
• InjurySep 30, 2026Overheating of Device

  Patient problems: Burning Sensation; Incontinence

  MAUDE report 50948696 ↗
• InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock; Insufficient Information; Pain

  MAUDE report 50948637 ↗
• InjurySep 30, 2026Electromagnetic Interference; Energy Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50948612 ↗
• InjurySep 30, 2026Disconnection; Migration or Expulsion of Device; Insufficient Device Problem Information

  Patient problems: Insufficient Information; Pain; Urinary Frequency / Polyuria

  MAUDE report 50947493 ↗
• MalfunctionSep 30, 2026Energy Output Problem; Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction It was reported that the reason for the call was the caller stated that for the past week or two they had been having issues with their handset and communicator not charging. The caller stated that it won't work, won't pick up, deactivate, or change the levels that they needed to change. The caller added that they were given a new cord, but that didn't resolve the issue. The caller did not have the equipment with them at the time of the call. The caller will call back with the equipment for further troubleshooting.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947434 ↗
• InjurySep 30, 2026Electromagnetic Interference; Failure to Deliver Energy

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for Urinary/bowel dysfunction. It was reported that ever since Wednesday when they had an MRI. They feel like they have more incontinence. Reviewed some therapy education information and redirected to their doctor. The patient (Pt) said they have not had any falls or traumas and yesterday had a swallowing test, 2 weeks ago they went to the ER due to problems with their heart, they had been on half a diuretic pill and went to one pill but when they were on one pill they are committed to being in the bathroom all the time so they had to go back to a half a pill. The patient (Pt) said they were on a diuretic before after another ER visit 2 months ago. The patient was redirected to their doctor.

  Patient problems: Incontinence; Insufficient Information

  MAUDE report 50947110 ↗
• MalfunctionSep 30, 2026Electromagnetic Interference; Energy Output Problem

  Information was received from a patient (pt) who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that they noticed today that the communicator was not responding and they didn't have a way to turn off their therapy as they pass through airport security gates. The pt mentioned the communicator would show a blinking yellow light for 60 seconds then would turn off. The pt stated they tried charging the communicator, but it didn't show any indicator lights. The pt added their programmer takes time to charge but was still working and had 67% battery life. The agent reviewed general therapy and device-use information and agent sent repair request to replace the communicator. The agent sent expedited delivery for the replacement. The agent called pt back to gather additional event information, pt answered and provided information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943077 ↗
• InjurySep 30, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that it helped their symptoms in the beginning but that did not last for more than a couple of weeks and now they are getting up 4-5 times a night or have to go every 45 minutes during the day. Pt said they met with the Medtronic rep (asked/unknown name/date) who put them on program C with cycling but when therapy came on it made their big toe curl and didn't help their symptoms, they turned therapy OFF the night before last and notice no difference in their symptoms when off or on. Pt said the doctor had the patient go for an xray and pt saw the wire looked a little crooked but the doctor didn't think it was an issue. Pt said they need to reset it again, the rep told them they would call in a couple of days but pt has waited several weeks but has not heard from the rep. Reviewed rep role, reviewed some therapy education, offered and assisted pt to use their equipment and pt was successful to change programs and increase confirming comfortable sensation. Pt to monitor the effect and continue working closely with their doctor. Offered and

  Patient problems: No Clinical Signs, Symptoms or Conditions; Sleep Dysfunction; Urinary Frequency / Polyuria

  MAUDE report 50942143 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that they just had the INS revised on Monday. The agent reviewed general therapy and device-use information. The pt changed the therapy program and increased therapy settings to a comfortable level.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942108 ↗
• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area; Insufficient Device Problem Information

  Patient problems: Ambulation or Postural Difficulties; Impaired Healing; Inappropriate Device Stimulation of Tissue; Incontinence; Insufficient Information; Pain

  MAUDE report 50938019 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Fluid Discharge; Unspecified Infection

  MAUDE report 50936874 ↗

Other Medtronic, Inc. products

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