VectrisRecalls & reported problems across all models

We found 4 models of Vectris 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 Feb 15, 2017 and Aug 17, 2026 — classified as 30 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (41 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 Vectris problems

Vectris models

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

• Vectris™ 977D260

  Stimulator, spinal-cord, totally implanted for pain relief
  52 reports
• Vectris™ 977D260

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  43 reports
• Vectris™ 977D260

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  41 reports
• Vectris™ 977D160

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 report

Recent Vectris adverse event reports

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

• InjuryAug 17, 2026Impedance Problem

  Information was received from a distributor regarding a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that the electric resistance was abnormal. A replacement was guaranteed. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285145 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SPINAL CORD STIMULATOR TRIAL WAS PERFORMED USING THE LEAD 977D260 TRIAL 5 MM COMPACT 1 X 8, AND THE TRIAL LEAD WAS REMOVED AFTER THE TRIAL; HOWEVER, DURING A LATER PLANNED PERMANENT SPINAL CORD STIMULATOR IMPLANT PROCEDURE, AN INTRAOPERATIVE X-RAY SHOWED THAT PART OF THE TRIAL LEAD HAD BEEN RETAINED IN THE PATIENT¿S BACK. THE PATIENT HAD PREVIOUSLY UNDERGONE MAGNETIC RESONANCE IMAGING FOR PRE-SURGICAL PLANNING, WAS EVALUATED BY A NEUROSURGEON, AND WAS SCHEDULED FOR THE PERMANENT IMPLANT. WHEN THE RETAINED FRAGMENT WAS IDENTIFIED IN THE OPERATING ROOM, IT WAS DECIDED TO REMOVE THE RETAINED TRIALLEAD FRAGMENT AND POSTPONE THE PERMANENT IMPLANT TO ALLOW HEALING. APPROXIMATELY 28 CM OF LEAD WAS REMOVED, AND PICTURES AND X-RAYS WERE TAKEN. THE REMOVED LEAD WAS RETAINED BY THE HOSPITAL AND SUBMITTED TO ITS RISK ANALYSIS DEPARTMENT. THE PATIENT REPORTEDLY DID NOT COMPLAIN OF ANY ADVERSE REACTION AFTER THE EARLIER LEAD REMOVAL, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25458065 ↗
• MalfunctionMay 29, 2026Human-Device Interface Problem; Material Twisted/Bent

  THE CALLER WAS A MANUFACTURER REPRESENTATIVE (REP) AND THE REASON FOR THE CALL WAS TO GET INFORMATION ABOUT THE RETURN MAILER. THE CALLER REPORTED THAT DURING AN IMPLANT CASE A LEAD BENT TOO EASILY. WHEN THE LEAD CAME OUT OF THE NEEDLE IT BENT IN HALF BETWEEN THE 0 AND 1 ELECTRODE. THE CALLER STATED THAT THEY WERE NOT SURE IF THE PHYSICIAN WAS APPLYING TOO MUCH FORCE. THE CALLER STATED THAT THEY HAVE SEEN OTHER LEADS BEND AT THE NEEDLE HUB BUT THIS LEAD BENT MORE SEVERELY. THE CALLER WILL RETURN THE LEAD FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331268 ↗
• MalfunctionMar 23, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN INTERNAL DEVICE. REP SAID THE PRODUCT WAS OPENED AND THE MEDICAL DOCTOR NOTICED DEFECT WITH THE LEAD TIP CONTACT. TROUBLESHOOTING WAS NOT PERFORMED. THE LEAD WAS NOT IMPLANTED AND WOULD BE RETURNED. NO SYMPTOMS WERE REPORTED. REP ACKNOWLEDGED THEY WOULD SUBMIT NEW INFORMATION THEY BECAME AWARE OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665437 ↗
• MalfunctionDec 29, 2025Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED REGARDING AN IMPLANTABLE DEVICE. THE DOCTOR SAID THE LEAD WOULD NOT PASS THROUGH THE NEEDLE. TROUBLESHOOTING WAS PERFORMED. WHEN IT WAS PASSED OFF THE FIELD IT WAS FOUND TO PASS THROUGH THE NEEDLE BUT THE PROVIDER WANTED IT EXAMINED ANYWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906910 ↗
• InjuryDec 18, 2025Break; Break

  IT WAS REPORTED THAT THE GUIDE WIRE TOOK THE TIP OF THE LEAD (PLASTIC PART) OFF WHEN HE WAS ADJUSTING THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838690 ↗
• InjuryNov 21, 2025Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO THE PHYSICIAN DUE TO NOT BEING ABLE TO PASS THE TRIAL LEAD PAST ADHESIONS OR SCAR TISSUE. THE PATIENT HAD ALSO GONE THROUGH A TRIAL BACK IN (B)(6) 2025 AND THE TRIAL WAS NOT COMPLETED AS THE LEADS CAME OUT OF THE EPIDURAL SPACE. THIS WAS A RE-TRIAL FOR THIS PATIENT. THE CAUSE WAS UNKNOWN. THE PHYSICIAN STATED THE ISSUE WAS DUE TO SCARRING OR ADHESIONS THAT WOULD NOT LET THE LEAD TO TREAD. THE PROCEDURE WAS THEN ABORTED. IN RECOVERY, THE PATIENT EXPRESSED SEVERE PAIN IN THE RIGHT THAT WAS NOT PRESENT PRIOR TO THE TRIAL PROCEDURE ATTEMPT. THE PHYSICIAN WAS NOTIFIED AND PRESCRIBED PAIN MEDICATION AND STEROID MEDICATION AND THE PATIENT WAS DISCHARGED FROM THE FACILITY TO GO HOME. THE PATIENT HAS A FOLLOW-UP APPOINTMENT ON (B)(6) 2025.

  Patient problems: Adhesion(s); Pain; Scar Tissue

  MAUDE report 23618805 ↗
• MalfunctionNov 14, 2025Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A USER REPORT. IT WAS REPORTED THAT THE REASON THE SPINAL CORD STIMULATION LEAD WAS IMPLANTED UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) TO TREAT POSTHERPETIC NEURALGIA. THEY HAD BEEN DIAGNOSED WITH POSTHERPETIC NEURALGIA AFTER BEING ADMITTED WITH RIGHT THORACIC AND DORSAL POSTHERPETIC PAIN FOR 4 WEEKS. DURING THE PROCEDURE, IT WAS FOUND THAT THE DIAMETER OF THE PUNCTURE NEEDLE SHEATH DID NOT MATCH THAT OF THE LEAD, RESULTING IN THE INABILITY OF THE LEAD TO PASS THROUGH THE NEEDLE INTO THE EPIDURAL SPACE. AFTER REPLACING THE PUNCTURE NEEDLE, THE LEAD WAS ABLE TO ENTER NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553769 ↗
• MalfunctionAug 27, 2025Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  THE REP REPORTED THE DAMAGE TO THE LEAD WAS NOTED PRIOR TO USE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903128 ↗
• MalfunctionAug 5, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WAS A TEST LEAD FAILURE; THE LEAD PUNCTURE NEEDLE WAS FOUND TO BE BENT DURING THE OPERATION. THE BENT NEEDLE WAS NOTICED WHEN OPENING THE PACKAGING DURING THE SURGERY. THE LEAD KIT WAS REPLACED TO COMPLETE THE OPERATION THE SAME DAY; THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722437 ↗
• MalfunctionJun 9, 2025Connection Problem; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THAT NEW IMPLANT LEADS WERE USED FOR REPLACEMENT BECAUSE THEY HAD A TRIAL BEFORE THIS ISSUE AND HAD USED ALL OF THE BACK-UP TRIAL LEADS. REP REPORTED RETUNNELING WAS NOT REQUIRED AND THE PROCEDURE WAS COMPLETED WITH IMPLANT LEADS. THE INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN. REP WILL RETURN THE LEADS FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168897 ↗
• MalfunctionMay 12, 2025Break; Break

  THE DEVICES WERE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003280 ↗
• MalfunctionApr 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD. THE REP REPORTED THEY OPENED THE LEAD KIT AND REALIZED IT WAS CRACKED AND NEVER PUT ON THE FIELD. THE CAUSE WAS UNKNOWN. NO PATIENT WAS INVOLVED WITH THE EVENT. THE PRODUCT WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866223 ↗
• InjuryMar 7, 2025Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). ATTEMPTED PLACEMENT, MD GOT A WET TAP AT T11/12 AND WAS UNABLE TO ACCESS EPIDURAL SPACE AT A HIGHER LEVEL DESPITE MULTIPLE ATTEMPTS. NO ACTION TAKEN/NO ADVERSE OUTCOME. THE ISSUE WAS RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21545687 ↗
• MalfunctionMar 3, 2025Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTI MULATOR (INS). REP REPORTED A DIFFICULT LEAD PLACEMENT DUE TO A DAMAGED STYLET. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505445 ↗

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