INTERSTIMRecalls & reported problems across all models
Medtronic, Inc. · 30 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one INTERSTIM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 24,415
- Deaths reported
- 7
- Injuries reported
- 11,486
- Recalls
- 1
We found 30 models of INTERSTIM by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 24,415 adverse event reports in the FDA's MAUDE database, received between May 20, 2009 and Sep 30, 2026 — classified as 7 deaths, 11,486 injuries, 12,922 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5,128 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Reports received per month, all models
INTERSTIM 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.
- Jul 6, 2023Class IIOpen, Classified
Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
Z-2365-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported INTERSTIM problems
Device problems
- Insufficient Device Problem Information5,128
- Adverse Event Without Identified Device or Use Problem4,369
- Failure to Deliver Energy3,819
- Device Operates Differently Than Expected3,622
- Inappropriate/Inadequate Shock/Stimulation2,627
- Unintended Collision2,534
- Migration or Expulsion of Device2,451
- Energy Output Problem2,066
Patient problems
- Therapeutic Effects, Unexpected5,180
- Pain5,124
- Incontinence3,941
- Therapeutic Response, Decreased3,592
- No Known Impact Or Consequence To Patient3,241
- No Clinical Signs, Symptoms or Conditions3,224
- Complaint, Ill-Defined3,031
- Insufficient Information2,863
INTERSTIM models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INTERSTIM® 3058Stimulator, electrical, implantable, for incontinence6 deaths23,065 reports
- INTERSTIM® 3058Stimulator, electrical, implantable, for incontinence817 reports
- INTERSTIM® 3023Stimulator, electrical, implantable, for incontinence1 death147 reports
- INTERSTIM® 3023Stimulator, electrical, implantable, for incontinence110 reports
- INTERSTIM® 3889-28Stimulator, electrical, implantable, for incontinence56 reports
- InterStim™ 041826Stimulator, electrical, implantable, for incontinence1 recall0 reports
- InterStim™ 306001Stimulator, electrical, implantable, for incontinence27 reports
- INTERSTIM® 3889-28Stimulator, electrical, implantable, for incontinence26 reports
- INTERSTIM® 305901Stimulator, electrical, implantable, for incontinence25 reports
- InterStim™ 306001Stimulator, electrical, implantable, for incontinence25 reports
- INTERSTIM® 3889-28Stimulator, electrical, implantable, for incontinence22 reports
- INTERSTIM® 3889-28Stimulator, electrical, implantable, for incontinence18 reports
- InterStim™ 309201Stimulator, electrical, implantable, for incontinence17 reports
- InterStim™ 309201Stimulator, electrical, implantable, for incontinence11 reports
- INTERSTIM® 3889-33Stimulator, electrical, implantable, for incontinence9 reports
- InterStim™ 3560022Stimulator, electrical, implantable, for incontinence8 reports
- INTERSTIM 3889-28Stimulator, electrical, implantable, for incontinence5 reports
- INTERSTIM® 3889-33Stimulator, electrical, implantable, for incontinence4 reports
- INTERSTIM 3093-28Stimulator, electrical, implantable, for incontinence3 reports
- INTERSTIM® 3093-28Stimulator, electrical, implantable, for incontinence3 reports
- INTERSTIM® 3889-33Stimulator, electrical, implantable, for incontinence3 reports
- INTERSTIM® 3889-33Stimulator, electrical, implantable, for incontinence3 reports
- InterStim™ 3560030Stimulator, electrical, implantable, for incontinence3 reports
- INTERSTIM® 305901Stimulator, electrical, implantable, for incontinence2 reports
- INTERSTIM 3889-33Stimulator, electrical, implantable, for incontinence1 report
- INTERSTIM® 3093-33Stimulator, electrical, implantable, for incontinence1 report
- INTERSTIM® 3889-41Stimulator, electrical, implantable, for incontinence1 report
- INTERSTIM® 309101Stimulator, electrical, implantable, for incontinence1 report
- InterStim™ 3560031Stimulator, electrical, implantable, for incontinence1 report
- InterStim™ 041839Stimulator, electrical, implantable, for incontinence1 report
Recent INTERSTIM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Break; Electromagnetic Interference; Unintended Collision; Insufficient Device Problem Information
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50952878 ↗MalfunctionSep 30, 2026Premature Discharge of Battery; Insufficient Device Problem Information
Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (INS) for u urinary dysfunction/sacral nerve stim It was reported that the device is no longer working and probably only lasted 1.5 to 2 years. .The patient was redirected to their healthcare provider to further address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947774 ↗MalfunctionSep 30, 2026Battery Problem; Loss of Data; Electromagnetic Compatibility Problem; Insufficient Device Problem Information
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for gastrointestinal/ pelvic floor, urinary dysfunction/sacral nerve stim It was reported that they noticed today that they cannot access their therapy settings. The patient mentioned that they had a heart procedure earlier today and had the INS turned off right after the procedure when they were trying to access their therapy settings to turn the INS back on when they encountered a message, 'The data has been lost. Please contact your clinician." The agent reviewed general therapy and device-use information and redirected the pt to their HCP to check the status of their INS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947519 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for gastrointestinal/pelvic floor therapy. It was reported that they didn't have a managing physician to monitor their implant. They reported they still had the InterStim implant; however, they would like to have it removed as about a month ago they said that it started to hurt. The patient said they would contact their healthcare provider (HCP) to discuss. The agent told the patient to provide an update once their InterStim devices were removed. The agent documented the event, no further action taken by Patient Services.
Patient problems: Pain
MAUDE report 50946577 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945944 ↗InjurySep 30, 2026Migration or Expulsion of Device; Communication or Transmission Problem
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for Gastrointestinal pelvic floor. It was reported that the INS was hurting their hip and described it as 'spiraling out of control' and it started about 3 days ago. The patient mentioned that they don't know whether it's about the control or something that moves inside. The patient mentioned that they went to Mexico and was redirected by their healthcare provider (HCP) to call MDT. The agent educated patient on general use of external devices. The agent walked patient through connecting to INS. The agent instructed the patient to connect to the implant with and without the antenna. The patient saw the same stimulation screen for poor communication. The agent instructed to reposition programmer try again; however, they saw possible EOS settings. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to arrange INS replacement and further address the issue.
Patient problems: Insufficient Information; Pain
MAUDE report 50944406 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor. It was reported that had to have INS removed because it started hurting and burning their leg.
Patient problems: Burning Sensation; Pain
MAUDE report 50937363 ↗MalfunctionSep 29, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932523 ↗InjurySep 29, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932048 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Impaired Healing; Wound Dehiscence
MAUDE report 50931959 ↗InjurySep 29, 2026Failure to Interrogate; Migration or Expulsion of Device; Vibration; Communication or Transmission Problem; Insufficient Device Problem Information
Patient problems: Sleep Dysfunction
MAUDE report 50927561 ↗MalfunctionSep 28, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924316 ↗InjurySep 28, 2026Insufficient Device Problem Information
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor. It was reported that the device was removed because it stopped working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919094 ↗MalfunctionSep 28, 2026Failure to Interrogate; Battery Problem; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917637 ↗MalfunctionSep 28, 2026Electromagnetic Interference; Battery Problem
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor. It was reported that the caller reported seeing a message on the handset that said 'data lost, internal device has lost all data, contact your clinician.' Caller stated they were with the patient trying to put the device into MRI mode this morning when the message appeared. Caller confirmed there were no falls or trauma to the area prior to seeing the message. Caller also mentioned that the patient had a CT scan when they arrived at the hospital, but they did not have the handset with them at the time of that scan. The issue was not resolved through troubleshooting. Agent reviewed MRI scanning guidelines and suggested the patient follow up with their healthcare provider to further address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915634 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
- Medtronic Azure Pacemaker12 models · 16,566 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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