Axoguard HA+ Nerve Protector AGHA48Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850828007145), received between Oct 8, 2024 and Dec 5, 2025 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT A CUBITAL TUNNEL RELEASE FOLLOWING A TOTAL ELBOW REPLACEMENT WHERE AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED AND THE PATIENT EXPERIENCED PERSISTENT PAIN. ON AN UNKNOWN DATE, PATIENT UNDERWENT A TOTAL ELBOW REPLACEMENT. FOLLOWING SURGERY, PATIENT HAD PAIN AND NO RETURN OF MOTOR FUNCTION. ON (B)(6) 2025, PATIENT UNDERWENT A CUBITAL TUNNEL RELEASE WITH AXOGUARD HA+ NERVE PROTECTOR IMPLANTATION. ON (B)(6) 2025 PATIENT WENT TO A NEW SURGEON DUE TO NO CHANGE IN SYMPTOMS. WHEN THE SITE WAS OPENED, SURGEON NOTED AREA APPEARED AS A SEVERELY TETHERED PLANE OF SCAR TISSUE. THE SURGEON HAD TO REMOVE THE HA+ LAYERS WHICH APPEARED THICK WITH BANDS ADHERING TO THE NERVE. IT WAS NOTED THAT THERE WERE SEVERE COMPRESSION POINTS DUE TO SCAR PROXIMAL AND DISTAL TO WHERE THE HA+ HAD PREVIOUSLY BEEN PLACED. PREOPERATIVELY, THE ULNAR NERVE SHOWED A FLICKER ON THE EMG. INTRAOPERATIVELY, THE EMG SHOWED NO ULNAR FUNCTION. THERE WERE NO CULTURES/PATHOLOGY PERFORMED. NO TREATMENT OR OUTCOME INFORMATION AVAILABLE. SURGEON DID NOT REPORT CAUSALITY. AXOGEN ASSESSED CAUSALITY OF PAIN AS UNLIKELY. SINCE THE PAIN WAS PRESENT PRIOR TO HA+ IMPLANTATION, IT IS UNLIKELY THAT THE DEVICE WOULD B

  Patient problems: Pain

  MAUDE report 23729388 ↗
• InjuryMay 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT UNDERWENT A THE SECOND REVISION OF THE CUBITAL TUNNEL RELEASE, WHICH WAS THE THIRD OPERATION PERFORMED ON (B)(6) 2024, WHICH INVOLVED THE IMPLANTATION OF A DEVICE.FOLLOWING THIS, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 FROM THE MEDIAN NERVE AT THE ELBOW (CUTR) AFTER INFECTION WAS REPORTED. IT'S IMPORTANT TO RECOGNIZE THAT ANY SURGICAL INTERVENTION CARRIES A RISK OF INFECTION, AS THE INCISION IN THE SKIN CAN PROVIDE A PATHWAY FOR POTENTIAL INFECTIVE AGENTS. WHILE THE SPECIFIC CAUSE OF THE INFECTION COULD NOT BE DETERMINED, IT WAS OBSERVED THAT THERE WAS A 30-DAY PERIOD BETWEEN THE SURGICAL INTERVENTION AND DRAINAGE.

  Patient problems: Bacterial Infection

  MAUDE report 22107412 ↗
• InjuryMay 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A CUBITAL TUNNEL RELEASE SURGERY ON (B)(6) 2024, DURING WHICH A DEVICE WAS IMPLANTED. THIS DEVICE WAS LATER EXPLANTED FOLLOWING SURGERY ON (B)(6) 2025. THE PATIENT HAS A LONG-STANDING HISTORY OF DIABETES, AND THE PAIN AT THE SITE OF THE PREVIOUS NERVE DECOMPRESSION (CUBITAL TUNNEL RELEASE) DID NOT HAVE A SPECIFIC DETERMINED CAUSE. BASED ON DISCUSSIONS WITH THE SURGEON, THERE ARE SEVERAL POSSIBILITIES FOR THE PAIN: SUBOPTIMAL NERVE PERFUSION DUE TO CHRONIC DIABETIC NEUROPATHY, CLINICALLY PRESENTING AS CHRONIC NEURITIS WITH PAIN AT THE INNER ELBOW; SIGNIFICANT SCARRING FROM THE PREVIOUS SURGERY THAT COULD COMPRESS THE NERVE; TETHERING OF THE ULNAR NERVE DURING THE HEALING PROCESS AFTER THE DECOMPRESSION; OR A COMBINATION OF THESE FACTORS. THE APPLICATION OF THE PRODUCT AFTER THE ULNAR NERVE DECOMPRESSION DOES NOT INDICATE THAT IT IS THE SOLE CAUSE OF THE PAIN, PARTICULARLY AS THE PATIENT DID NOT SHOW SIGNS OF REDNESS OR SWELLING TYPICALLY ASSOCIATED WITH TRUE ALLERGIC REACTIONS. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE OBSERVED OUTCOME IS CONNECTED TO THE IMPLANTED PRODUCT.

  Patient problems: Hyperresponsive to stimuli

  MAUDE report 22036844 ↗
• InjuryApr 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT UNDERWENT A CUBITAL TUNNEL RELEASE SURGERY ON (B)(6) 2024, DURING WHICH A DEVICE WAS IMPLANTED. THIS DEVICE WAS LATER EXPLANTED FOLLOWING A SUBSEQUENT SURGERY ON (B)(6) 2025. A GENERAL COMPLAINT WAS FILED WITH THE AXOGEN REPRESENTATIVE ON (B)(6) 2025, NOTING THAT THE PATIENT EXPERIENCED INTENSE PAIN AT THE SURGICAL SITE. SYMPTOMS INCLUDED PAIN INDICATIVE OF COMPRESSION ON THE NERVE AT THE SURGICAL SITE. NO OTHER INFORMATION WAS SHARED AND MEDICAL ANALYSIS IS PENDING.

  Patient problems: Pain

  MAUDE report 21861521 ↗
• InjuryNov 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SURGEON PERFORMED A BILATERAL CARPAL TUNNEL RELEASE SURGERY. THE ISSUE AROSE AFTER THE REMOVAL OF THE SKIN STITCHES, LEADING TO THE DEHISCENCE OF THE PROXIMAL INCISION, WHICH ULTIMATELY REQUIRED THE AXOGUARD HA+ NERVE PROTECTOR TO BE PROPHYLACTICALLY REMOVED ON (B)(6) 2024 TO ELIMINATE ANY POTENTIAL RISKS FROM A FOREIGN BODY IN AN INFECTED FIELD. WOUND DEHISCENCE CAN BE INFLUENCED BY VARIOUS FACTORS, INCLUDING POTENTIAL NON-COMPLIANCE WITH POSTOPERATIVE INSTRUCTIONS BY THE PATIENT. THIS NON-COMPLIANCE MAY HAVE ALLOWED BACTERIA TO ENTER THE WOUND, RESULTING IN AN INFECTION. HOWEVER, THERE IS INSUFFICIENT EVIDENCE TO ESTABLISH A DIRECT LINK BETWEEN THE REPORTED ADVERSE EVENT OF WOUND COMPLICATIONS AND THE AXOGUARD HA+NERVE PROTECTOR THAT WAS INTACT THROUGHOUT THE POSTOPERATIVE PERIOD.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 20668018 ↗
• InjuryOct 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A DIABETIC PATIENT UNDERWENT CARPAL TUNNEL REVISION SURGERY AND RECEIVED AN AXOGUARD HA+ NERVE PROTECTOR ON (B)(6) 2024. THE DEVICE WAS EXPLANTED ON (B)(6) 2024 DUE TO THE PATIENT SUFFERING FROM SOME WOUND COMPLICATIONS AFTER PATIENT REMOVED WOUND DRESSING AS INSTRUCTED. THERE IS A POSSIBILITY FOR ALLERGIC REACTION, BUT DETECTION OF NEUTROPHILS OR EOSINOPHILS IN THE CULTURE WAS NOT REPORTED FOLLOWING DISCUSSION WITH THE PA, WHICH MAKES IT HARD TO DRAW ANY DEFINITIVE CONCLUSION. CONTRIBUTING FACTORS MAY INCLUDE USE OF CELECOXIB WHICH MAY POTENTIALLY IMPACT OR DELAY THE IMMUNE RESPONSE AND MACROPHAGE INFILTRATIONS NECESSARY FOR DEVICE REMODELING AS WELL AS PATIENT'S DIABETES STATUS, WHICH MAY CONTRIBUTE TO DELAYED WOUND HEALING AND CELLULITIS. THERE IS INSUFFICIENT EVIDENCE TO CONCLUDE THAT THE REPORTED ADVERSE EVENT OF WOUND COMPLICATIONS WAS RELATED TO THE AXOGUARD HA+NERVE PROTECTOR.

  Patient problems: Bacterial Infection

  MAUDE report 20395481 ↗