Altaviva™ P7850NRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000936433), received between Nov 26, 2025 and Sep 29, 2026 — classified as 16 injuries.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50938413 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT PATIENT HAD SUSPECTED INFECTION AT IMPLANT SITE. PATIENT EXPERIENCED PAIN, DISCOMFORT, SWELLING, FLUID DISCHARGE, REDNESS, INCISION REOPENING AND BLEEDING. NURSE PRACTITIONER TREATED AS THEY SAW FIT WITH ANTIBIOTICS. NOT CONFIRMED WITH CULTURE. THE CAUSE WAS UNKNOWN AND IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: Discomfort; Erythema; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 25635575 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY HAD PAIN AND SWELLING AT THE IMPLANT SITE SINCE IMPLANT ON (B)(6) 2026 BUT THE SWELLING WOULD IMPROVE WHEN THEY WOULD ELEVATE THEIR LEGS. THE SYMPTOMS GOT WORSE AROUND 3 DAYS AFTER IMPLANT AND IT WAS EXTREMELY PAINFUL TO WALK AND PATIENT HAD TO USE A CRUTCH OR A CANE. PATIENT WAS CURRENTLY AT THE ER AND THE ER DOCTOR SAID THE IMPLANT SITE WAS INFECTED BECAUSE IT WAS RED AND SWOLLEN BUT THEY WERE DOING FURTHER BLOODWORK TO CONFIRM. PATIENT SERVICES (PSS) RECOMMENDED PATIENT FOLLOW UP WITH MANAGING HEALTHCARE PROVIDER (HCP) WHEN THEY ARE ABLE. PATIENT ALSO REQUESTED THAT MANUFACTURER FIELD STAFF BE MADE AWARE OF THE INFECTION AND AN EMAIL COMMUNICATION WAS SENT.

  Patient problems: Ambulation or Postural Difficulties; Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25509401 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY HAD AN INFECTION AT THE INCISION SITE. THEY PUT NEOMYCIN/POLYMYXIN B/BACITRACIN AND A BAND-AID OVER THE INCISION BUT THEN ALL OF A SUDDEN WHEN THEY WENT TO THE DOCTOR TO HAVE IT LOOKED AT, IT WAS GOOEY AND RED. THEY HAD BEEN ON ANTIBIOTICS FOR 10 DAYS AND IT WAS HEALING.

  Patient problems: Erythema; Fluid Discharge; Unspecified Infection

  MAUDE report 25360775 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD VASCULAR NECROSIS ON ANKLE THAT WAS IMPLANTED. NECROSIS WAS NEARLY AS BIG AS A QUARTER. THE PHYSICIAN MENTIONED THAT THEY PROBABLY SHOULDN'T HAD IMPLANTED DEVICE AND THEY WOULD BE MORE CAREFUL IN THE FUTURE. PATIENT PROVIDED ANTIBIOTICS. THE PHYSICIAN DID NOT THINK THE DEVICE CAUSED THIS ISSUE BUT RATHER PATIENT CONDITION UPON IMPLANTATION. PATIENT WAS EXPLANTED. PATIENT WAS SAD THOUGH BECAUSE THE DEVICE WAS WORKING. THE ISSUE WAS RESOLVED.

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 25320369 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE RIGHT LEG AROUND THE IMPLANT SITE SINCE MAY 12TH. PATIENT TOOK A COURSE OF ANTIBIOTICS AND THE DEVICE WAS EXPLANTED YESTERDAY IN THE OFFICE.

  Patient problems: Unspecified Infection

  MAUDE report 25279253 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT WENT TO ER, BLOOD CULTURES RAN, STAPH INFECTION IN BLOOD. DOCTOR SAID IMPLANT SITE LOOKED GOOD, NO REDNESS OR SWELLING AND DEVICE CAME OUT VERY EASY. DEVICE REMOVED AS PRECAUTION.

  Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222865 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTI MULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THE REP CALLED IN TO REPORT A POTENTIAL INFECTION OR DELAYED WOUND HEALING. THE REP FOUND OUT ABOUT THE ISSUE A FEW HOURS AGO DURING THE 6-WEEK POST OP VISIT WITH THE PHYSICIAN ASSISTANT (PA). PA STATED THAT AT THE 2-WEEK FOLLOW UP INCISION CHECK, ALLERGIC REACTION TO ADHESIVE, THE ALLERGY WAS MENTIONED AT THAT TIME BY THE PATIENT (PATIENT DAUGHTER ACKNOWLEDGED THAT THEY FAILED TO REPORT ALLERGY ON DAY OF PROCEDURE). THERE WAS A DISTINCT BORDER/OUTLINE MATCHING THE ADHESIVE DRESSING. THE REP WAS NOT NOTIFIED OF THIS AT THE TIME. HOWEVER, THE PA REPORTS THAT THE INCISION SITE LOOKS "DIFFERENT TODAY COMPARED TO THE 2-WEEK FOLLOW-UP." PA SAID THEY BELIEVED IT COULD BE "DELAYED WOUND HEALING DUE TO AGE," AS THE PATIENT ALSO REPORTED "BUMPING THE INCISION SITE ALSO THE DAY AFTER THE PROCEDURE." THEY REPORTED THE PATIENT IS ALSO ON BLOOD THINNERS. 3 DAYS OF ANTIBIOTICS WERE ORDERED AND THE PA PLANS TO CHECK IN WITH THE PATIENT WITHIN A WEEK. THEY WILL PROVIDE THE REP WITH AN UPDATE AFTER. ADD

  Patient problems: Cyst(s); Erythema; Impaired Healing; Insufficient Information; Rash; Unspecified Infection

  MAUDE report 25113413 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT CAME INTO HCP. OFFICE ON (B)(6) 2026, PATIENT WAS STARTED ON AUGMENTIN ANTIBIOTIC FOR 14 DAYS DUE TO INCISION INFECTION, THE INFECTION STARTED ON (B)(6) 2026. CALLER REPORTS PATIENT HAD BEEN APPLY OINTMENT ON THE INCISION WHICH RESULTED ON ALLERGIC REACTION, PHYSICIAN INFORMED PATIENT TO STOP THE OINTMENT. CALLER REPORTS PATIENT IS SCHEDULED TO SEE PHYSICIAN ON (B)(6) 2026.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 24860625 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT PHYSICIAN SENT ATTACHED IMAGES VIA TEXT AND COMMENTED THAT THE PATIENT WHO WENT LINE DANCING AFTER THEIR IMPLANT EVEN THOUGH INSTRUCTED NOT TO. PATIENT REPORTED THE INCISION SITE WAS RED AND THAT HAD BEEN LINE DANCING. WAS STARTED ON ANTIBIOTICS BUT AGAIN WENT LINE DANCING AFTER PHYSICIAN INSTRUCTED THEM NOT TO AND COULD CAUSE FURTHER ISSUES WITH THEIR HEALING. THE IMAGES OF THE WOUND WAS FROM THE PATIENT AND THE OTHER IS FROM THE PHYSICIAN PRIOR TO EXPLANT. ADDITIONAL INFORMATION WAS RECEIVED ON 2026-APRIL-07, THE REP STATED THE DEVICE WAS NOT EXPLANTED. THE INFECTION CLEARED UP.

  Patient problems: Unspecified Infection

  MAUDE report 24605775 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THEY FIRST GOT A TEXT FROM HEALTHCARE PROVIDER (HCP) OFFICE ON (B)(6) 2026 STATING THERE WAS A PATIENT WHO HAD AN EXPLANT DUE TO INFECTION AND EXPLANTED DEVICE WAS GOING TO BE PROVIDED TO REP, BUT THEY COULD NOT FIND IT AFTER EXPLANT. HCP OFFICE FOUND THE DEVICE ONE MONTH AFTER, REP PICKED IT UP AND SENT DEVICE IN WITH RP PAPERWORK. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THERE WAS REDNESS, SWELLING AND PUS. ANTIBIOTICS WERE GIVEN DURING SURGERY. ORAL ANTIBIOTICS GIVEN FOR 10 DAYS AFTER SURGERY THEN ADDITIONAL 7 DAYS. PATIENT DID NOT HAVE DIABETES. UNKNOWN IF A1C WAS 7 PERIOPERATIVELY. PATIENT CLINICAL STATUS WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24536541 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTION AT THE INCISION SITE OF THE IMPLANT. THE PATIENT EXPERIENCED REDNESS, SWELLING, FLUID DISCHARGE, PUS DISCHARGE, AND WARMTH. THE HCP REMOVED THE DEVICE WITH NO FUTURE PLANS TO IMPLANT AGAIN. PATIENT IS BEING TREATED WITH ANTIBIOTICS AT THE HOSPITAL AS IN PATIENT.

  Patient problems: Burning Sensation; Erythema; Fluid Discharge; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24415406 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT WENT TO THE HOSPITAL WITH AN INFECTION AT THE IMPLANT SITE. PATIENT HAD REDNESS, SWELLING, AND FLUID DISCHARGE. PATIENT WAS GIVEN ANTIBIOTICS, INFECTION RESOLVED, AND PATIENT IS DOING BETTER.

  Patient problems: Erythema; Fluid Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24392819 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTED INFECTION RESOLVED AFTER ADMINISTRATION OR ANTIBIOTICS. IT WAS UNKNOWN IF ANY ADDITIONAL INTERVENTIONS WERE TAKEN OR PLANNED.

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 24323157 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL WHERE IT WAS DETERMINED THAT THE IMPLANT SITE WAS INFECTED WHICH WAS RELATED TO THE DEVICE/THERAPY. THE PATIENT HAD PAIN, INCISION REOPENING, REDNESS, SWELLING, FLUID DISCHARGE, PUS DISCHARGE, AND WARMTH. PATIENT WAS EMITTED FOR IV ANTIBIOTICS. THE PATIENT WAS IN HOSPITAL SCHEDULED TO HAVE THEIR IMPLANT EXPLANTED TODAY, (B)(6) 2026.

  Patient problems: Burning Sensation; Erythema; Fluid Discharge; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 24313879 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF REDNESS AND WARMTH AT THEIR INCISION SITE. THE HCP SAW THEM LATER THAT DAY AND IT WAS DETERMINED THAT THE DEVICE NEEDED TO BE EXPLANTED. IT WAS NOTED THAT THE PATIENT HAS SEVERAL ALLERGIES AND THE HCP THOUGHT THIS COULD PERHAPS BE AN ALLERGIC REACTION TO THE SILICONE COATING OF THE DEVICE. IT WAS ALSO NOTED THAT IT WAS A SUSPECTED INFECTION; THEY EXPERIENCED REDNESS, WARMTH/HOT, AND DISCHARGE/WOUND WEEPING. ANTIBIOTICS WERE REQUIRED AND EXPLANT WAS PLANNED FOR THE AFTERNOON OF (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE. THE HCP VIA THE REP STATED THAT THEY WERE SURE THIS WAS A CASE OF ALLERGIC REACTION AND NOT INFECTION. THEY STATED THAT THE POCKET WAS DRY, AND THE WOUND WAS NOT HOT; IT WAS RED AND LOOKED IRRITATED, BUT THERE WAS NO HEAT. THE REP STATED THAT THEY WERE SURE THE HCP SENT THE PATIENT HOME WITH ANTIBIOTICS AFTER OPENING THE INCISION BACK UP. WHEN ASKE

  Patient problems: Burning Sensation; Erythema; Fluid Discharge; Hypersensitivity/Allergic reaction; Post Operative Wound Infection; Skin Inflammation/ Irritation

  MAUDE report 23658778 ↗