Vectris™ SureScan® 977A275 (UDI 00763000324285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000324285), received between Mar 24, 2023 and Jan 9, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT DURING A PATIENT'S CASE, THE PROCEDURE HAD TO BE ABORTED DUE TO THE INABILITY TO GAIN ACCESS INTO THE EPIDURAL SPACE. DESPITE MULTIPLE ATTEMPTS TO ACCESS, THIS WAS UNSUCCESSFUL AND THE DECISION WAS MADE TO STOP THE PROCEDURE FOR PATIENT SAFETY. AS A RESULT, ONE LEAD WAS OPENED AND USED DURING THE ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024190 ↗
• MalfunctionOct 15, 2025Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP) REGARDING A LEAD. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DOCTOR WAS TRYING TO ACCESS THE EPIDURAL SPACE USING THE STRAIGHT NEEDLE THAT CAME FROM THE LEAD KIT. AFTER MULTIPLE ATTEMPTS, SHE NOTICED THAT SHE WAS GETTING LOSS OF RESISTANCE, BUT THE LEAD WOULD NOT GO THROUGH THE END OF THE NEEDLE. SHE PULLED THE NEEDLE OUT OF THE PATIENT'S BODY TO EXAMINE IT, AND SHE NOTICED THAT THE VERY END OF THE NEEDLE WAS BENT - WHICH SHE DETERMINED WAS THE CAUSE OF THE ISSUE. SHE WAS NOT SURE HOW THE NEEDLE GOT BENT, BUT IT WAS CONCERNING AS IT HAD ORIGINALLY SHOWED NO BEND TO IT. THEN, SHE USED A DIFFERENT NEEDLE, AND SHE WAS ABLE TO GET THE LEAD THROUGH THE SPACE AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299570 ↗
• MalfunctionApr 30, 2025Break; Material Twisted/Bent; Positioning Problem; Break; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE LEAD, RESISTANCE WAS MET WHILE ADVANCING THE LEAD. UPON REMOVAL, THE GUIDEWIRE WAS FOUND TO BE BENT. HCP REQUESTED A NEW LEAD KIT FOR A REPLACEMENT GUIDEWIRE. THE GUIDEWIRE FROM THE NEW KIT WAS USED TO SUCCESSFULLY ADVANCE THE LEAD. NO IMPEDANCES WERE FOUND, AND INTRAOPERATIVE TESTING SHOWED GOOD PATIENT COVERAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937062 ↗
• MalfunctionApr 1, 2025Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  MANUFACTURER REPRESENTATIVE (REP) REPORTED THE PRODUCT WAS OPENED IN THE OPERATING ROOM WHEN IT WAS FOUND THAT THE PACKAGING APPEARED TO HAVE BEEN DAMAGED DURING SHIPPING. REP WAS NOT COMFORTABLE WITH THE INTEGRITY OF THE STERILE SEAL AND THE PRODUCT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740250 ↗
• InjuryAug 21, 2024Break; High impedance; Break; High impedance

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT ON (B)(6) 2024 THE PATIENT (PT) WOULD BE HAVING THEIR LEAD REVISED DUE TO AN ISSUE WITH THE LEAD.  THE REP REPORTED THE LEAD CONTACTS WERE NO LONGER WORKING AND HIGH IMPEDANCES WERE MEASURED.  THE REP ALSO REPORTED THE PT WAS NO LONGER RECEIVING PAIN RELIEF AND HAD A RETURN OF PAIN. AS A RESULT, THE LEAD WOULD BE REVISED AND THEY NOTED THE IMPLANTED NEUROSTIMULATOR (INS) WOULD BE UPGRADED.  NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 2024-AUG-19, THEY REPORTED BOTH LEADS WERE REVISED. IT WAS REPORTED TO BE UNKNOWN WHEN THE PT FIRST NOTICED THE LOSS OF PAIN RELIEF / RETURN OF PAIN. IN RESPONSE TO POTENTIAL CONTRIBUTING FACTORS TO THIS EVENT, THE REP STATED THE PT MENTIONED PLAYING BASKETBALL. THE REP REPORTED THE FACILITY KEPT THE EXPLANTED DEVICES, THEY WILL NOT BE RETURNED FOR ANALYSIS AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20020137 ↗
• MalfunctionMay 2, 2024Positioning Problem; Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED, FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED, THAT THE PHYSICIAN DID HAVE TROUBLE STEERING THE LEAD. POSSIBLY, DUE TO SCAR TISSUE. REP REPORTED, THEY DID NOT NOTICE ANY OTHER FACTORS. REP NOTED, THE PHYSICIAN DID BEND BOTH STYLETS TRYING TO STEER THE LEAD. AND THAT WAS WHEN, THEY ASKED FOR ANOTHER LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230621 ↗
• InjuryMar 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD IMPLANTABLE LEADS. THE LEADS WERE IMPLANTED THEN EXPLANTED ON THE SAME DAY AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NEVER OPENED. PATIENT CURRENTLY DOES NOT HAVE ANY IMPLANTS. AN IDC WITH INCORRECT INFORMATION WAS MAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611889 ↗
• InjuryMar 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD IMPLANTABLE LEADS. THE LEADS WERE IMPLANTED THEN EXPLANTED ON THE SAME DAY AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NEVER OPENED. PATIENT CURRENTLY DOES NOT HAVE ANY IMPLANTS. AN IDC WITH INCORRECT INFORMATION WAS MAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611861 ↗

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