SurpassRecalls & reported problems across all models
Nevro Corp. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 289
- Deaths reported
- 1
- Injuries reported
- 271
- Recalls
- 0
We found 4 models of Surpass by Nevro Corp. in the FDA's device registry (GUDID). Together they are named in 289 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Sep 24, 2026 — classified as 1 death, 271 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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
Reports received per month, all models
Most reported Surpass problems
Device problems
- Adverse Event Without Identified Device or Use Problem266
- Insufficient Device Problem Information14
- Fracture8
- Migration6
- Detachment of Device or Device Component4
- Break3
- Disconnection1
- High impedance1
Patient problems
- Hematoma68
- Unspecified Infection60
- Pain33
- Paralysis31
- Neurological Deficit/Dysfunction28
- Numbness23
- Insufficient Information20
- Cerebrospinal Fluid Leakage17
Surpass models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surpass™ LEAD3005-50BStimulator, Spinal-Cord, Totally Implanted For Pain Relief133 reports
- Surpass™ LEAD3005-70BStimulator, Spinal-Cord, Totally Implanted For Pain Relief1 death121 reports
- Surpass LEAD2005-70BStimulator, Spinal-Cord, Totally Implanted For Pain Relief21 reports
- Surpass LEAD2005-90BStimulator, Spinal-Cord, Totally Implanted For Pain Relief14 reports
Recent Surpass adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection associated with an epidural abscess. The HCP does not believe the infection was device-related. The patient was hospitalized, and the device was subsequently removed. No further complications related to this event have been reported.
Patient problems: Abscess; Insufficient Information; Unspecified Infection
MAUDE report 50884856 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50859028 ↗InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE. THE EVENT WAS DETERMINED NOT TO BE DEVICE RELATED. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 25738866 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 25352982 ↗MalfunctionMay 25, 2026Break
IT WAS REPORTED THAT THE PATIENT'S LEAD ARE BROKEN AND ARE IMPLANTED IN THE PATIENT, ONLY THE DEVICE WAS EXPLANTED DUE TO MALFUNCTIONING. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25271693 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING DEVICE PLACEMENT, THE PATIENT EXPERIENCED NUMBNESS IN THE RIGHT LEG. THE PHYSICIAN DOES NOT THINK THAT THE IMPLANTS ALONE CAUSED ANY ISSUES. THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED. THE PATIENT REPORTEDLY FEELS WELL FOLLOWING THE PROCEDURE.
Patient problems: Numbness
MAUDE report 25260800 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE LEAD WAS PLACED, THE PATIENT EXPERIENCED LOSS OF SENSATION IN THE FEET. THE PHYSICIAN ABORTED THE PROCEDURE, AND THE LEAD WAS REMOVED. FOLLOWING THE PROCEDURE, THE PATIENT APPEARED TO MOVE HER FEET APPROPRIATELY AND WAS REPORTEDLY DOING WELL. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Patient problems: Numbness
MAUDE report 25150305 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING PAIN, SPORADIC ELECTRICAL SHOCKING SENSATIONS, NUMBNESS, AND WEAKNESS IN HIS LOWER EXTREMITIES. THE PATIENT REPORTS SUSTAINING WORSENING NEUROLOGICAL INJURY THE LONGER THE LEADS WERE IMPLANTED THE MORE SEVERE AND PERMANENT THE NERVE DAMAGE BECAME. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE.
Patient problems: Muscle Weakness/Atrophy; Nerve Damage; Numbness; Pain
MAUDE report 25086786 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING PAIN, SPORADIC ELECTRICAL SHOCKING SENSATIONS, NUMBNESS, AND WEAKNESS IN HIS LOWER EXTREMITIES. THE PATIENT REPORTS SUSTAINING WORSENING NEUROLOGICAL INJURY THE LONGER THE LEADS WERE IMPLANTED THE MORE SEVERE AND PERMANENT THE NERVE DAMAGE BECAME. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE.
Patient problems: Muscle Weakness/Atrophy; Nerve Damage; Numbness; Pain
MAUDE report 25086714 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 25044695 ↗InjuryApr 30, 2026Migration
IT WAS REPORTED THAT THE PATIENT¿S PADDLE LEAD DID NOT APPEAR TO BE IN AN OPTIMAL MIDLINE POSITION FOLLOWING THE IMPLANT PROCEDURE. UPON ACTIVATION OF THERAPY, THE PATIENT EXPERIENCED SYMPTOMS INCLUDING PAIN, NUMBNESS, DECREASED STRENGTH, AND LOSS OF NERVE FUNCTION, AS WELL AS URINARY CONTINENCE ISSUES REQUIRING REHABILITATION. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED, AND THE PADDLE LEAD WAS REPOSITIONED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.
Patient problems: Nerve Damage; Numbness; Pain; Urinary Incontinence
MAUDE report 25043464 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION. PHYSICIAN BELIEVES IT COULD BE DUE TO IMPROPER CARE OF THE SURGICAL SITES AROUND THE TOP INCISION. THE PATIENT HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 24861058 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATES THAT THE PATIENT DEVELOPED NEW-ONSET SPINAL CORD SYMPTOMS ASSOCIATED WITH A TIGHT FIT AND AN EPIDURAL HEMATOMA. SHE SUBSEQUENTLY UNDERWENT AN EXTENSION LAMINECTOMY; HOWEVER, THIS PROCEDURE DID NOT RESOLVE THE SYMPTOMS OF SPINAL CORD IMPINGEMENT. THE DEVICE WAS ULTIMATELY EXPLANTED.
Patient problems: Hematoma; Numbness
MAUDE report 24859749 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 24747139 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEG PAIN FOLLOWING THE IMPLANT PROCEDURE. A CT SCAN INDICATED THAT THE PADDLE WAS EXERTING PRESSURE ON A HERNIATED DISC. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.
Patient problems: Limb Pain
MAUDE report 24744863 ↗
Other Nevro Corp. products
All Nevro Corp. devices →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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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