OmniaRecalls & reported problems across all models

We found 2 models of Omnia by Nevro Corp. in the FDA's device registry (GUDID). Together they are named in 1,585 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2019 and Sep 30, 2026 — classified as 332 deaths, 1,251 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (111 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 Omnia problems

Omnia models

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

• Omnia NIPG2500

  Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
  318 deaths1,532 reports
• Omnia NIPG2500

  Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
  14 deaths53 reports

Recent Omnia adverse event reports

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

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient acquired an infection. Per the HCP, the infection was not related to the device but was attributed to wound healing issues. The patient was hospitalized, treated with oral and IV antibiotics, and subsequently underwent device removal. There have been no reports of further complications related to this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50946836 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection accompanied by an allergic reaction. According to the medical assessment, the infection was not believed to be device-related. The patient was hospitalized and treated with medication. No further complications related to this event have been reported.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Unspecified Infection

  MAUDE report 50927287 ↗
• InjurySep 25, 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: Insufficient Information; Unspecified Infection

  MAUDE report 50897618 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50860226 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50860077 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection that resulted in a wound issue, which is still healing. A medical assessment from the physician regarding the nature of the infection was not available. The patient underwent device removal, and no further complications related to this event have been reported.

  Patient problems: Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 50858484 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced worsening pain due to the implant. The patient had the device removed. There have been no reports of further complications regarding this event.

  Patient problems: Pain

  MAUDE report 50858471 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced numbness, shocking and heat sensations, and scar tissue buildup. The patient¿s right upper buttock, where the device was implanted, became hardened and developed a significant infection with tissue necrosis. The patient underwent surgical removal of the infected and damaged tissue and was left with permanent scarring as a result. A medical assessment from the physician regarding the nature of the infection and the other reported medical issues was not available. The patient subsequently had the device removed, and there have been no further reports of complications related to this event.

  Patient problems: Burning Sensation; Insufficient Information; Necrosis; Numbness; Pain; Unspecified Infection

  MAUDE report 50817651 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced dizziness and lower leg pain, resulting in a loss of balance and a fall down a flight of stairs at home. The patient also experienced pain that began at the base of the skull and radiated to the lower neck and shoulders. Subsequently, the patient was diagnosed with gastroparesis and continues to seek treatment for this condition to date. The patient also reported a permanent injury that required hospitalization. A medical assessment from the physician regarding the cause of the reported events was not available. The patient had the device removed.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Dizziness; Pain

  MAUDE report 50817609 ↗
• InjurySep 17, 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 was treated with antibiotics; there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50805869 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced wound dehiscence following a fall. A medical assessment from the physician regarding the cause of the reported event was not available. The patient was treated with antibiotics, and there have been no reports of further complications regarding this event.

  Patient problems: Wound Dehiscence

  MAUDE report 50174298 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain, as well as irritation at her kidneys. A medical assessment from the physician regarding the cause of the reported event was not available. The patient had the device removed. There have been no reports of further complications regarding this event.

  Patient problems: Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 50173978 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced shocking sensations. The patient underwent a revision procedure during which the device was replaced. No further complications have been reported regarding this event.

  Patient problems: Pain

  MAUDE report 50098690 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain. A medical assessment from the physician regarding the cause of the reported event was not available. The patient had the device removed. There have been no reports of further complications regarding this event.

  Patient problems: Pain

  MAUDE report 50060709 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a staph infection behind the spinal cord stimulator. A medical assessment from the physician regarding the nature or cause of the reported infection was not available. The patient was hospitalized. There have been no reports of further complications related to this event.

  Patient problems: Bacterial Infection

  MAUDE report 50039446 ↗

Other Nevro Corp. products

• Senza13 models · 2,854 reports
• Surpass4 models · 289 reports