Vectris™ SureScan® 977A260 (UDI 00763000324278)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00763000324278), received between Jun 2, 2022 and Sep 23, 2026 — classified as 16 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

9 other recalls cover devices cleared under the same FDA submission (P840001); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Positioning Problem

  It was reported that during an attempted implant procedure of two LEAD 977A260 5MM COMPACT 1X8 MRI leads, the patient underwent multiple unsuccessful attempts to place electrodes. The leads could not be maintained in a dorsal position, and two wet taps occurred during the procedure. The implant procedure was aborted, neither lead was implanted, and the leads were removed. The patient had a midline incision over the upper lumbar and lower thoracic area and was referred to neurosurgery for paddle implant placement. The issue was resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50868198 ↗
• InjurySep 23, 2026Positioning Problem

  It was reported that during an attempted implant procedure of two LEAD 977A260 5MM COMPACT 1X8 MRI leads, the patient underwent multiple unsuccessful attempts to place electrodes. The leads could not be maintained in a dorsal position, and two wet taps occurred during the procedure. The implant procedure was aborted, neither lead was implanted, and the leads were removed. The patient had a midline incision over the upper lumbar and lower thoracic area and was referred to neurosurgery for paddle implant placement. The issue was resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50868195 ↗
• MalfunctionMay 1, 2026Break; Difficult to Insert

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT SURGEON WAS NOT ABLE TO REINSERT THE STYLET ONCE IT WAS REMOVED. REP SAID SURGEON HAD TO USE ANOTHER LEAD. REP TO SEND LEAD BACK FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056109 ↗
• MalfunctionApr 9, 2026Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT, PRIOR TO USE, THE IMPLANTABLE LEAD WAS FOUND WITH CRACKED PACKAGING AND THE DEVICE WAS NEVER IMPLANTED. DUE TO QUESTIONABLE STERILITY OF THE PRODUCT INSIDE, THEY DID NOT USE THE PRODUCT. THE LEAD COMPONENTS INSIDE THE PACKAGING WERE DISCARDED BY THE CUSTOMER, AND THE CRACKED PACKAGING WAS RETAINED FOR RETURN. THERE WAS NO PATIENT INVOLVED. 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 24831952 ↗
• MalfunctionMar 9, 2026Difficult to Insert; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER INITIAL PLACEMENT OF THE LEAD, THE PHYSICIAN ATTEMPTED TO REINSERT THE STYLET TO ASCEND THE LEAD TIP HIGHER AND DISCOVERED A BLOCKAGE AT THE DISTAL END OF THE LEAD, WHICH WAS POTENTIALLY A BLOOD CLOT. MULTIPLE ATTEMPTS WERE MADE TO THREAD THE STYLET, BUT THESE WERE UNSUCCESSFUL. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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 24546270 ↗
• MalfunctionJan 26, 2026Impedance Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE DOCTOR WAS PLACING THORACIC PERC LEADS AND THE ENTIRE LEAD WAS LIT UP RED WHEN CHECKING THE CONNECTION IN THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). THIS WAS A DEVICE ISSUE WHEN CONNECTING A NEW LEAD TO A NEW WENS, ALL CONNECTIONS WERE RED. THE PATIENT DIDN¿T EXPERIENCE AN ISSUE. THE ISSUE WAS A LEAD ISSUE OUT OF THE BOX. AFTER TESTING THE LEAD CONNECTION IN THE WENS, THE LEAD WAS MOVED TO THE OTHER SIDE OF THE WENS (0-7 TO 8-15) AND THE LEAD CONNECTIONS WERE ALL STILL RED. REP OPENED A NEW LEAD AND THEIR WERE NO ISSUES AT ALL. ALL CONNECTIONS WERE GOOD ON THE SAME WENS. THE CAUSE WAS NOT KNOWN. THE ISSUE WAS RESOLVED. THE DEVICE WAS IN REP'S POSSESSION. WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183682 ↗
• MalfunctionDec 30, 2025High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT'S IMPLANT PROCEDURE. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES. MANUFACTURER REPRESENTATIVE (REP) CHECKED CONNECTIONS WITH LEAD IN BOTH CHANNELS (0-7 AND 8-15) OF EXTERNAL NEUROSTIMULATOR AND THE SAME ELECTRODE SHOWED THE HIGH IMPEDANCE VALUE ON ELECTRODE 4 OR 12 DEPENDING ON THE CHANNEL. THE LEAD WAS THEN PLACED INTO THE NEUROSTIMULATOR AND CONTINUED TO SHOW HIGH IMPEDANCE VALUE ON ONE ELECTRODE SO THE PHYSICIAN REQUESTED A NEW LEAD. CAUSE IS NOT KNOWN, BUT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923544 ↗
• MalfunctionDec 9, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER ATTEMPTING TO PLACE THE LEAD 977A260 5MM COMPACT 1X8 MAGNETIC RESONANCE IMAGING (MRI) AND REMOVING IT FROM THE STYLET, THE LEAD WAS FOUND TO BE FRACTURED, DAMAGED, AND BROKEN. THE DEVICE WAS NEVER IMPLANTED. THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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 23756437 ↗
• InjuryNov 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THERE WAS AN ANCHOR ISSUE. REP REPORTS A LEAD MIGRATION OR DISLODGEMENT OCCURRED. PRODUCTS DID NOT MIGRATE AROUND OR ENTANGLE INTERNAL ORGANS. NO STIMULATION ISSUES WERE REPORTED AS A RESULT OF THIS ISSUE. LEADS WERE EXPLANTED. REP REPORTS THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636265 ↗
• InjuryNov 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THERE WAS AN ANCHOR ISSUE. REP REPORTS A LEAD MIGRATION OR DISLODGEMENT OCCURRED. PRODUCTS DID NOT MIGRATE AROUND OR ENTANGLE INTERNAL ORGANS. NO STIMULATION ISSUES WERE REPORTED AS A RESULT OF THIS ISSUE. LEADS WERE EXPLANTED. REP REPORTS THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636248 ↗
• MalfunctionNov 12, 2025High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  INS IS NEW AND IMPLANTED NOTHING WAS WRONG WITH THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533996 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THE LEAD SERIAL NUMBERS.

  Patient problems: Perforation

  MAUDE report 23300431 ↗
• InjurySep 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THE LEAD SERIAL NUMBERS.

  Patient problems: Perforation

  MAUDE report 23109729 ↗
• MalfunctionSep 12, 2025Material Deformation; Material Twisted/Bent; Positioning Problem; Material Deformation; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT THE LEAD WAS NOT IMPLANTED. MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE LEAD WAS BENT WHILE ATTEMPTING TO GAIN ACCESS TO EPIDURAL SPACE TO IMPLANT AND UNABLE TO STEER EVEN WITH A DIFFERENT STYLET. THEY HAD TO OPEN A NEW LEAD TO USE WHICH WORKED FINE. ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039545 ↗
• MalfunctionSep 2, 2025Break; Break

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945305 ↗
• MalfunctionJun 27, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED WHEN THE LEAD KIT WAS OPENED BY THE OPERATION ROOM STAFF, THE SCRUB TECHNICIAN NOTICED A SMUDGE ON THE INSIDE OF THE STERILE PLASTIC COVER. AFTER EXAMINATION IT APPEARED TO BE THE GLUE THAT IS USED ON THE PAPER. CAUSE IS UNKNOWN. NO SYMPTOMS WERE REPORTED. IT WAS REPORTED THAT PRODUCT WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350422 ↗
• MalfunctionJun 12, 2025Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE LEAD 977A260 5MM COMPACT 1X8 MAGNETIC RESONANCE IMAGING (MRI), THE LEAD WAS KINKED AND COULD NOT BE ADVANCED, WITH SIGNIFICANT RESISTANCE ENCOUNTERED DURING ATTEMPTED ADVANCEMENT. THE HEALTHCARE PROFESSIONAL CHANGED THE STYLET IN AN ATTEMPT TO RESOLVE THE ISSUE BUT WAS STILL UNABLE TO ADVANCE THE LEAD. THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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 22194290 ↗
• MalfunctionMay 7, 2025Break; Break

  AFTER OPENING LEAD FOR PROCEDURE HOSPITAL STAFF NOTICED THE LEAD COULD BE FRAYED. THEREFORE LEAD WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977000 ↗
• MalfunctionApr 18, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  2025-MAR-19: INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) WHO REPORTED WHEN THE LEAD KIT WAS OPENED THEY NOTICED IT WAS COMPROMISED. THEY REPORTED THE THERE WAS AN OUT OF BOX FAILURE AS THE LEAD TRAY WAS BROKEN. NO SYMPTOMS WERE REPORTED. (B)(6) 2025: MANUFACTURER REPRESENTATIVE (REP) STATED THE LEAD KIT TRAY WAS OPENED IN THE PACKAGE. REP TO SEND BACK PRODUCT WITH THE TRAY. TECHNICAL SERVICES TOLD REP THEY CAN SEND IT BACK WITHOUT USING THE RETURN KIT MAILER SINCE THE TRAY WON'T FIT IN THE MAILER. OOB ISSUE. 2025-MAR-21: ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED THE PHYSICAL TRAY WHICH HELD THE LEAD COMPONENTS WAS VISUALLY COMPROMISED. THEY PROVIDED TRACKING DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865897 ↗
• InjuryApr 15, 2025Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING SURGERY INVOLVING THE LEAD, THE STYLET WAS CHANGED MULTIPLE TIMES, AND ON THE FOURTH CHANGE, THE STYLET WOULD NOT GO IN ALL THE WAY. IT WAS NOTED THAT DAMAGE WAS CAUSED OR DISCOVERED DURING SURGERY. THE PRODUCT WAS EXPLANTED. NO TROUBLESHOOTING WAS PERFORMED. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21839223 ↗
• MalfunctionApr 9, 2025Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping; Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED LEAD WAS OPENED TO SCRUB TECH AND THE INTERNAL STERILE PACKAGING HAD MOISTURE IN IT. CAUSE WAS UNKNOWN; WILL BE RETURNING THE LEAD IN ITS PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21808695 ↗
• MalfunctionFeb 12, 2025Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT WHEN THE REP WHEN TO USE THE PRODUCT FOR AN IMPLANT THEY NOTICED THE INTERNAL PACKAGE WAS COMPLETELY DESTROYED AND NOT STERILE. THE OUTSIDE PACKAGE WAS UNDAMAGED. THE DEVICE WAS NOT USED WITH A PATIENT SO THERE WAS NO PATIENT INVOLVEMENT. THE CAUSE IS UNKNOWN, BUT THE DEVICE WILL BE RETURNED. THE REP NOTED THEY WOULD SUBMIT ANY NEW INFORMATION THAT BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363517 ↗
• MalfunctionJan 28, 2025Break; Material Deformation; Positioning Problem; Break; Material Deformation; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING AN ATTEMPT TO IMPLANT A LEAD, THE LEAD WAS FRACTURED, DAMAGED, OR BROKEN. THE PATIENT HAD A SIGNIFICANT AMOUNT OF SCAR TISSUE, WHICH CONTRIBUTED TO DIFFICULTIES IN STEERING THE LEAD, RESULTING IN A BEND. TROUBLESHOOTING STEPS INCLUDED CHANGING STYLETS AND APPLYING LIGHT FORCE TO IMPLANT THE LEAD, BUT THE LEAD COULD NO LONGER BE STEERED. THE ISSUE REMAINS ONGOING. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Scar Tissue

  MAUDE report 21252033 ↗
• MalfunctionJan 27, 2025Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED LEAD WAS OPENED ON THE STERILE FIELD, PHYSICIAN EXAMINED LEAD AND DETERMINED IT WAS BENT MORE THAN NORMAL IN THE OPPOSITE DIRECTION OF ORIGINAL BEND. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246262 ↗
• MalfunctionJan 17, 2025Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). PHYSICIAN CLAIMED THE LEAD FELT DIFFERENT TO PREVIOUS LEADS AND HE HAD MORE TROUBLE DRIVING IT THAT USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis