VerifyRecalls & reported problems across all models

We found 6 models of Verify by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 137 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2016 and Sep 23, 2026 — classified as 65 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (45 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 Verify problems

Verify models

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

• Verify® 353101

  Stimulator, electrical, implantable, for incontinence
  40 reports
• Verify™ 353101

  Implanted electrical device intended for treatment of fecal incontinence
  29 reports
• Verify® 353101

  Implanted electrical device intended for treatment of fecal incontinence
  24 reports
• VERIFY™ 3531

  Stimulator, electrical, implantable, for incontinence
  23 reports
• Verify™ 353101

  Stimulator, electrical, implantable, for incontinence
  15 reports
• Verify™ 3531

  Stimulator, electrical, implantable, for incontinence
  6 reports

Recent Verify adverse event reports

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

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, information was received from a manufacturer representative and patient regarding a trial patient who was using an external neurostimulator (ENS) for Urgency Frequency and Urge Incontinence. It was reported that the trial was initiated on (b)(6)2026. It was reported that yesterday they started to have a presumed potential allergic reaction. The caller was not with the patient at the time of the call, but stated the patient called them last night and reported the issue. Agent sent the caller the spec sheets for the lead and extension to caller. The patient (Pt) to follow up with managing healthcare provider (HCP). Additional information was received from the patient on (b)(6). The patient stated that they had a rash ever since the procedure. It was unknown if the issue was resolved. On (b)(6) 2026, additional information was received from the patient. It was reported that they were itchy and they had papular rash along their lower back and lead insertion site. They removed the lead and percutaneous extension. The issue was resolved.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 50866092 ↗
• InjurySep 1, 2026Break; Difficult to Remove

  Information was received from a manufacturer representative regarding a trial patient who was using an external neurostimulator (ENS) for unknown indications for use. The trial began on 2026-Jul-07. It was reported that  the patient cut their leads so they were still implanted. The caller clarified that this account performed the trial for three days and sends instructions home with the patient for them to remove their own leads. The caller stated patient wasn't able to get their leads out so they cut them. The caller stated the physician took the patient back to the OR for permanent implant today and tried to see if they could find the remaining portions of basic evaluation leads but was not able to visualize them in the procedure and wasn't going to perform further surgery in an attempt to locate them. Caller stated physician performed imaging and was able to see the remains on an AP view but not on a lateral view. Therefore, the physician had no indication of how deep the lead remnants were but confirmed they were still implanted. Agent reviewed MRI information from  manual which stated patient should not be exposed to MRI during test stim. Agent and caller discussed programming

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50536823 ↗
• MalfunctionMay 25, 2026Difficult to Insert

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. THEIR TRIAL STARTED ON (B)(6) 2026. IT WAS REPORTED THAT THE TRIAL LEAD WOULD NOT ADVANCE WITH STYLET. THE PHYSICIAN WAS UNABLE TO ADVANCE THE TRIAL LEAD INTO THE NEEDLE HUB. THE STYLET KEPT SLIDING THROUGH THE ELECTRODE END OF LEAD CREATING NO STRUCTURE TO BE ABLE TO INSERT TRIAL LEAD INTO NEEDLE HUB. THE PHYSICIAN WAS UNABLE TO INSERT LEAD PROPERLY INTO 3.5 FORAMEN NEEDLE. THEY HAD TO GET ANOTHER TRIAL LEAD TO USE. THEY HAD NO ISSUES ADVANCING NEW TRIAL LEAD. TROUBLESHOOTING WAS PERFORMED BY ADJUSTING THE STYLET SEVERAL TIMES, AND ATTEMPTING REINSERTION BUT THE LEAD KEPT SLIDING OFF THE STYLET. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE MANUFACTURING REPRESENTATIVE (REP) INDICATED THE STYLET KEPT COMING OUT, SO THEY HAD TO USE ANOTHER LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267871 ↗
• MalfunctionMay 19, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM THE PATIENT (PT) REGARDING A TRIAL EXTERNAL NEUROSTIMULATOR (ENS). THE REASON FOR THE CALL WAS THE PATIENT REPORTED THAT LAST NIGHT, AFTER THEY GOT HOME FROM THE HCP'S OFFICE, THEY WERE TRYING TO GET OUT OF THE RECLINER CHAIR, THEY FELT A STRONG TUG ON THE WIRES (REFERRING TO THE LEAD), AND THEY FELT A LOCALIZED PAIN ON THE WIRE, AND ADDED THAT IT'S SORE ON THE LEFT SIDE. AGENT REDIRECTED THEM TO THE HCP TO HAVE THE DEVICE CHECKED, BUT THE PATIENT KEEP ON INSISTING TO JUST HAVE IT CHECKED BY ADJUSTING THE THERAPY SETTING, STATING THAT IF THEY FELT THE STIMULATION ON THE RIGHT SPOT, THEN THE "WIRES" PROBABLY IS JUST FINE. PATIENT MENTIONED THAT THEY WERE SUPPOSED TO INCREASE THE STIMULATION ON THE RIGHT SIDE, WHICH THEY WERE ABLE TO DO LAST NIGHT, AND THEY FELT THE SENSATION ON THE RIGHT SPOT, BUT WHAT THEY ARE WORRIED WAS THE LEFT SIDE, BECAUSE THERE'S WHERE THEY FEEL LIKE THE LEAD GOT DISLODGED. PATIENT WANTED TO SHIFT THERAPY ON THE LEFT SIDE TO CHECK IF THEY WOULD FEEL THE STIMULATION, BUT THEY ADDED THAT THEY WERE SPECIFICALLY TOLD BY THE HCP TO NOT SHIFT SIDES. AGENT REVIEWED THAT PATIENT AND TECHNICAL SERVICES (PATS) CAN WALK THEM THROUGH WITH TH

  Patient problems: Discomfort; Pain

  MAUDE report 25219429 ↗
• MalfunctionMay 5, 2026Failure to Deliver Energy; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY. IT WAS REPORTED THAT THE TRIAL WAS INITIATED ON (B)(6) 2026 IT WAS REPORTED THAT THE LEADS HAD COME LOOSE RESULTING TO SEEING ERROR MESSAGE "COMMUNICATION ERROR: NO LEADS ATTACHED. SERIAL NUMBER (B)(6)". THEY TAPPED RETRY BUT SAME ERROR SHOWED. THE PATIENT EXPERIENCING LOSS OF STIMULATION AND LOSS OF THERAPY AS ISSUES RELATED TO THE MIGRATION. THE PATIENT WAS ADVISED TO CONTACT CLINICIAN. THEY ALSO MENTIONED PATIENT'S FOOT WENT NUMB LAST (B)(6) 2026. THE EVENT WAS NOTIFIED TO MANUFACTURER REPRESENTATIVE (REP). THE ISSUE WAS NOT RESOLVED AND IT WAS STILL ONGOING.

  Patient problems: Insufficient Information; Numbness

  MAUDE report 25076998 ↗
• MalfunctionApr 14, 2026Break; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. THEIR TRIAL STARTED ON (B)(6) 2026. IT WAS REPORTED THAT THE WIRE DETACHED. THERE WAS MIGRATION/LEAD MOVED/WIRE MOVED. IT WAS UNKNOWN WHETHER THERE A CONNECTOR MIGRATION. IT WAS UNKNOWN WHETHER THE PRODUCT MIGRATE AROUND OR ENTANGLE INTERNAL ORGANS. PATIENT MENTIONED THE WIRES WERE PULLED BUT NO BLEEDING. THERE WAS BROKEN LEAD/LEAD DAMAGED/LEAD CUT. THE CAUSE OF THE ISSUE WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE ISSUE WAS NOT RESOLVED AND WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24869543 ↗
• MalfunctionMar 12, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. THEIR TRIAL STARTED ON (B)(6) 2026. IT WAS REPORTED THAT THE LEAD STYLET APPEARED TO BE DAMAGED WHEN PHYSICIAN PULLED THE LEAD OUT OF THE PROTECTIVE COVER AND ATTEMPTED TO INSERT INTO THE PATIENT. THE LEAD STYLET WAS SLIGHTLY PULLED OUT FROM THE LEAD AND WAS NOTICED THAT IT WAS BENT AT THE DISTAL PART OF THE STYLET. THEREFORE, THE LEAD COULD NOT BE USED AND AN EXTRA LEAD HAD TO BE UNPACKED. ANOTHER THING TO NOTICE WAS THAT IT WAS UNCLEAR WHICH LEAD WAS DAMAGED- UNSURE IF IT WAS THE LEAD THAT IS INCLUDED IN THE 309201 KIT WITH LOT #60694174 OR THE STAND ALONE LEAD WITH LOT #60676799 AS THEY WERE ALREADY PLACED DOWN IN THE SURGICAL FIELD DURING THE PROCEDURE. THE CAUSE OF THE ISSUE WAS UNKNOWN. IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578039 ↗
• MalfunctionFeb 27, 2026Failure to Interrogate; Migration or Expulsion of Device; Battery Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT (PT) WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR NON-OBSTRUCTIVE URINARY RETENTION. THE TRIAL BEGAN ON 2026-FEB-11 IT WAS REPORTED THAT THEY HAD COMMUNICATION ISSUE BETWEEN CONTROLLER AND ENS, UNABLE TO COMMUNICATE/CONNECT TO CONTROLLER. THERE WAS NO COMMUNICATION/COULDN'T COMMUNICATE. TROUBLESHOOTING WAS PERFORMED. PT CAME INTO THE OFFICE TO SEE NURSE PRACTITIONER (NP) FOR LEAD PULL FEB/17. THEY HAD NOT SEEN IMPROVEMENT IN SYMPTOMS. NP OPENED THE SMART PROGRAMMER WHICH GAVE COMMUNICATION ERROR: EXTERNAL DEVICE BATTERY HAS DEPLETED. LAST COMMUNICATION WITH PATIENT SHOWED THEY WERE ON LEFT LEAD, 0.9MA AND RATE OF 30 (PHYSICIAN REQUEST DUE TO HISTORY (HX) OF RETENTION). THE CAUSE WAS NOT KNOWN. THE ISSUE WAS RESOLVED. PATIENT EXPERIENCED MIXED RESULTS DURING THE TRIAL. NP WAS UNSURE AT WHAT POINT THE ENS DEPLETED. PT WOULD RETURN TO THE OFFICE IN 1 MONTH TO DISCUSS THE ADVANCED EVALUATION VS IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Retention

  MAUDE report 24466384 ↗
• MalfunctionFeb 24, 2026Overheating of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS UNKNOWN WHEN THE TRIAL WAS INITIATED. IT WAS REPORTED THAT ON 2026-FEB-12 THE LEAD WAS SCRAPPED AND REPORTED BOWEL LEAKAGE AND BURNED. THEY REPORTED LEAKS, CONSTANT MUCOUS, BROWN MODERATE AND PAD. THE LEAD WAS BURNED.

  Patient problems: Burning Sensation; Fecal Incontinence; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433393 ↗
• MalfunctionFeb 9, 2026Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP). WHEN THE HCP WAS ASKED TO PROVIDE THE STEPS TAKEN TO RESOLVE THE WIRES BEING PULLED OUT, THE HCP STATED THAT THE PATIENT HAD STAGE 2 PROCEDURE SCHEDULED ON (B)(6) 2026. THE HCP STATED THAT THE ISSUE WAS NOT YET RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24289824 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. WHEN ASKED TO CLARIFY THE STATEMENT, THEY REPORTED THAT THEY HAD BEEN FEELING LIKE THEY HAD TO PEE, BUT WHEN THEY GO TO THE BATHROOM, THEY DIDN'T NEED TO PEE AND IF THEY EXPERIENCED URINARY RETENTION, THEY STATED THAT THEY USED TO BUT NOT ANYMORE. THE PATIENT DID NOT EXPERIENCE URINARY RETENTION PRIOR TO THE DEVICE AND THE RETENTION DID NOT WORSEN AS A RESULT OF THE DEVICE OR THERAPY. IT WAS UNKNOWN IF CATHETERIZATION AS THE 'STANDARD OF CARE' PRIOR TO THE DEVICE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE DEVICE WAS INTENDED TO TREAT URGENCY FREQUENCY.

  Patient problems: Cramp(s) /Muscle Spasm(s); Micturition Urgency; Urinary Retention

  MAUDE report 23743436 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY. THE TRIAL BEGAN ON (B)(6) 2025. IT WAS REPORTED THAT THEY HAD SUSPECTED INFECTION AND THERE WERE NO ADDITIONAL SYMPTOMS REPORTED. THE ISSUE WAS NOT RESOLVED AND WAS STILL ONGOING. THE PATIENT WAS HOSPITALIZED AND THE PATIENT WAS ON THE WAY TO THE HOSPITAL TODAY ON (B)(6) 2025. ON (B)(6) PATIENT REPORTED THAT THEY HAD INFECTION AND IN A HURRY TO THE HOSPITAL TODAY. ADVISED TO CONTACT THEIR DOCTOR, IF SYMPTOMS PERSISTED.

  Patient problems: Unspecified Infection

  MAUDE report 23694141 ↗
• MalfunctionNov 7, 2025Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS UNKNOWN WHEN THE TRIAL WAS INITIATED. IT WAS REPORTED THAT THE LEAD GUIDE WIRE BROKE THROUGH COIL. THE LEAD WAS OPENED BUT UPON DISCOVERY OF THE ISSUE IT WAS SET ASIDE AND NOT USED. IT WAS UNKNOWN IF THE TROUBLESHOOTING WAS PERFORMED. THE CAUSE OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). WHEN THE REP WAS ASKED TO CLARIFY THE STATEMENT THAT THE LEAD GUIDE WIRE BROKE THROUGH COIL. THE REP STATED THAT THE COIL WAS OUTSIDE OF THE GUIDEWIRE AND WAS UNABLE TO BE THREADED BACK ON. THE REP STATED THAT THE CAUSE OF THE LEAD GUIDE WIRE BROKE THROUGH THE COIL WAS NOT DETERMINED. THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO THE PRODUCTION OF LEAD. WHEN ASKED ABOUT THE STEPS TAKEN TO RESOLVE THE ISSUE, THE REP STATED THAT THEY BROUGHT THE DOCTOR A NEW BASIC LEAD AND SENT IN THE BROKEN ONE TO DETERMINE. THE REP STATED THAT THE ISSUE WAS RESOLVED AND THEY GAVE THE DOCTOR A NEW LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494308 ↗
• MalfunctionOct 24, 2025Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information; Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS UNKNOWN WHEN THE PATIENT'S TRIAL BEGAN. IT WAS REPORTED THAT THEY WENT TO THEIR HEALTHCARE PROVIDER TODAY FOR A FOLLOW-UP APPOINTMENT AND THEY CHANGED THE AAAA BATTERIES IN THE IMPLANT BECAUSE IT WASN'T WORKING. PATIENT SAID WHEN THEY GOT HOME, THEY SAW A SYSTEM ERROR MESSAGE THAT SAID THERAPY MAY HAVE STOPPED AND TO CONTACT THEIR CLINICIAN. PATIENT ALSO SAW AN ERROR MESSAGE SAYING UNABLE TO COMMUNICATE WITH DEVICE, COMMUNICATION LOST, ENSURE EXTERNAL DEVICE IS WITHIN RANGE AND BATTERIES ARE IN PLACE, PRESS THE BUTTON ON THE EXTERNAL DEVICE IF YOU ARE STILL NOT CONNECTING TO DEVICE. PATIENT TRIED TO TROUBLESHOOT WITH THEIR NEIGHBOR, BUT THAT DIDN'T RESOLVE THE ISSUE. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AGENT REVIEWED MEANING OF MESSAGES AND REVIEWED THAT AAAA BATTERIES ARE LIKELY DEPLETED. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE LIKELY CAUSE WAS UNKNOWN. THEY HAVE THE IMPLANTED DEVICE AND IT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23385234 ↗
• MalfunctionOct 15, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE TRIAL WAS INITIATED ON (B)(6) 2025. IT WAS REPORTED THAT THEY WERE GETTING A MESSAGE ON THE PROGRAMMER THAT THERE WERE NO LEADS ATTACHED TO THE CABLE. CALLER CONFIRMED THE CABLE WAS PLUGGED INTO THE SIDE OF THE ENS BUT THE ERROR MESSAGE STILL PERSISTED. CALLER MENTIONED THEY COULD PREVIOUSLY SEE A LITTLE THIN WIRE THAT THEY CAN NO LONGER LOCATE AND NOTED THAT THERE WAS A LOT OF TAPE PRESENT AT THE TRIAL SITE. THE ERROR MESSAGE STARTED INTERMITTENTLY ON FRIDAY BUT OCCURRED AGAIN YESTERDAY AND WHEN THEY SPOKE WITH MANUFACTURER REPRESENTATIVE (REP) THEY SAID THAT IT MIGHT HAVE BEEN CAUSED BY THE PATIENT'S BODILY POSITION. THE PATIENT WAS REDIRECTED TO MANAGING HEALTHCARE PROVIDER (HCP) AND RECOMMENDED LETTING REP KNOW AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277347 ↗

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