Axoguard HA+ Nerve Protector AGHA36Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00850828007138), received between Nov 21, 2024 and Sep 25, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Purulent Discharge

  MAUDE report 50904241 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing; Purulent Discharge

  MAUDE report 50904113 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50904105 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  THIS IS AN INITIAL, SERIOUS, SPONTANEOUS REPORT REGARDING A FEMALE PATIENT (AGE UNKNOWN) WHO UNDERWENT A CUBITAL TUNNEL REVISION IN WHICH AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED ON (B)(6) 2024, AND SUBSEQUENTLY EXPERIENCED INCISION SITE INFLAMMATION, IMPLANT SITE PAIN, AND IMPLANT SITE SEROMA REQUIRING EXPLANT. FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED LOCALIZED REDNESS, IRRITATION, AND PAIN AT THE SURGICAL SITE. DUE TO PERSISTENT SYMPTOMS, THE HA+ DEVICE WAS EXPLANTED ON (B)(6) 2026.

  Patient problems: Inflammation; Pain; Seroma

  MAUDE report 25669274 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  THIS IS AN INITIAL, SERIOUS, SPONTANEOUS REPORT REGARDING A MALE PATIENT (AGE UNKNOWN) WHO UNDERWENT A CUBITAL TUNNEL REVISION IN WHICH AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED AND SUBSEQUENTLY EXPERIENCED INCISION SITE INFLAMMATION AND IMPLANT SITE PAIN REQUIRING EXPLANT. ON (B)(6) 2025, THE PATIENT UNDERWENT A CUBITAL TUNNEL REVISION PROCEDURE DURING WHICH AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED. FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED LOCALIZED REDNESS, IRRITATION, AND PAIN AT THE SURGICAL SITE. THE CONDITION WAS MONITORED FOR A PERIOD OF TIME; HOWEVER, DUE TO PERSISTENCE OF SYMPTOMS, THE HA+ DEVICE WAS EXPLANED ON (B)(6) 2025.

  Patient problems: Inflammation; Pain; Skin Inflammation/ Irritation

  MAUDE report 25666978 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  THIS IS AN INITIAL, SERIOUS, SPONTANEOUS REPORT REGARDING A PATIENT (UNKNOWN AGE/GENDER) WHO UNDERWENT REVISION CUBITAL TUNNEL SURGERY IN WHICH AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED AND SUBSEQUENTLY EXPERIENCED CUBITAL TUNNEL SYNDROME. ON (B)(6) 2024, THE PATIENT UNDERWENT A CUBITAL TUNNEL REVISION DURING WHICH AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED. THIS WAS PATIENT'S SECOND REVISION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS INCLUDING PAIN, REPORTED TO BE MORE PROXIMAL THAN ORIGINAL REVISION. ON (B)(6) 2026, SURGEON PERFORMED A THIRD CUBITAL TUNNEL REVISION, EXPLANTING A PORTION OF THE PREVIOUSLY IMPLANTED HA+ AND SUBSEQUENTLY PLACING ANOTHER AXOGUARD HA+ AT THE SITE.

  Patient problems: Neuralgia; Pain; Paresthesia

  MAUDE report 25334181 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PROCEDURE OVER DORSAL RADIAL SUPERFICIAL NERVE BRANCHES AND AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED. THE PATIENT EXPERIENCED INCISION SITE ERYTHEMA AND WOUND DEHISCENCE. ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF CHROMIC GUT SUTURES PLACED DURING THE PREVIOUS SURGERY DUE TO A REACTION, WITH NEUROLYSIS/NEUROMA, HA+ PLACED TO PROTECT THE NERVES.ON AN UNSPECIFIED DATE, AT THE FIRST POST-OP APPOINTMENT, THE PATIENT EXHIBITED A SMALL AREA OF REDNESS NEAR THE INCISION. THE INCISION THEN DEHISCED AND PROGRESSED TO AN OPEN WOUND. ON (B)(6) 2026, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR SURGICAL EXPLORATION, IRRIGATION AND DEBRIDEMENT (I&D), AND EXPLANT OF THE AXOGUARD HA+. CULTURES/PATHOLOGY WERE OBTAINED, BUT RESULTS HAVE NOT BEEN SHARED WITH AXOGEN AT THIS TIME. FURTHER TREATMENT INFORMATION, SURGICAL TECHNIQUE, AND EVENT OUTCOME ARE UNKNOWN. THE SURGEON REPORTED CAUSALITY AS NOT RELATED, STATED THAT THE PATIENT HAD A PREVIOUS REACTION TO FOREIGN MATERIAL, VARIOUS COMORBIDITIES, AND SEVERAL SURGERIES IN THIS SAME AREA. AXOGEN REPORTED CAUSALITY AS UNASSESSABLE DUE TO THE ABSENCE OF CULTURES/PATHOLOGY, MULTIPLE PLAUSIBLE ALTERNATIVE E

  Patient problems: Erythema; Wound Dehiscence

  MAUDE report 24519243 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, PATIENT UNDERWENT A CARPAL TUNNEL REVISION WITH AXOGUARD HA+ NERVE PROTECTOR. THIS WAS PATIENT'S SECOND SURGERY AT CARPAL TUNNEL SITE. SURGEON NOTED THE MEDIAN NERVE WAS ADHERENT TO TRANSVERSE CARPAL LIGAMENT, SOME ADHERENCE TO FLEXOR TENDONS, AND TENOSYNOVITIS. SURGEON DISSECTED SCAR TISSUE AROUND THE NERVE AND TENOSYNOVIUM, TRIMMED THE 3X6 WRAP TO 3X5, WRAPPED NERVE WITH HA+ WITH NO SUTURES, IRRIGATED, AND CLOSED SKIN WITH 4-0 NYLON (SINGLE LAYER CLOSURE). ON AN UNKNOWN DATE OVER A YEAR AFTER THE INITIAL SURGERY, PATIENT DEVELOPED A LUMP AT MIDPORTION OF THE SURGICAL SITE. ON (B)(6) 2025, PATIENT WENT BACK INTO SURGERY FOR A SUSPECTED GANGLION CYST WITH NEW SURGEON. NO CYST WAS FOUND. SURGEON NOTED NERVE LOOKED GOOD, FOUND UNUSUAL TISSUE ADHERED TO THE MEDIAN NERVE THAT LOOKED LIKE POSSIBLE REMNANTS OF THE HA+. ALSO NOTABLY, FOUND THICKNESS OF TENOSYNOVIUM. PATHOLOGY REPORT SHOWED A COMBINATION OF BENIGN SOFT TISSUE AND PALISADED HISTIOCYTIC INFLAMMATION WITH NECROBIOSIS. TISSUE WAS SCRAPED OUT BY SURGEON AT THIS TIME. ON (B)(6) 2025 PATIENT HAD A POST-OP FOLLOW UP WITH NURSING STAFF. NURSE NOTED PATIENT IS RECOVERING WELL, TAKING TYLENOL AND IBUPROFEN FOR POST-OP

  Patient problems: Adhesion(s); Fibrosis; Synovitis

  MAUDE report 23880062 ↗
• InjuryNov 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A FEMALE PATIENT WHO UNDERWENT AXOGUARD HA+ NERVE PROTECTOR IMPLANTATION DURING A CARPAL TUNNEL REVISION SURGERY, EXPERIENCED WOUND DEHISCENCE AND DEVICE EXTRUSION. ON (B)(6) 2025 PATIENT UNDERWENT CARPAL TUNNEL REVISION SURGERY. SURGEON USED AXOGUARD HA+ NERVE PROTECTOR (LOT LB1628887). ON (B)(6) 2025, PATIENT WENT TO FOLLOW UP APPOINTMENT WHERE THE WOUND WAS HEALING PROPERLY EXCEPT FOR THE BOTTOM PORTION WHICH WAS DEHISCED WITH A PIECE OF THE HA+ STICKING OUT. SURGEON PULLED THE PIECE OF HA+ OUT AND REP REPORTED IT LOOKED LIKE A "WEIRD, LONG, GOOEY PIECE." SURGEON WENT BACK INTO THE SURGICAL SITE AND NOTICED THE REMAINING PORTION OF THE HA+ WAS STILL ADHERED TO THE NERVE AND STATED HE WAS SURPRISED HOW WELL THE HA+ WAS PROTECTING THE NERVE. THE SURGEON LEFT THE REMAINING PORTION OF HA+ IN PLACE. CULTURES WERE REPORTED AS NEGATIVE, NO COPY OF REPORT AVAILABLE. PATHOLOGY REPORTED FIBROUS AND FIBRINOUS TISSUE ADMIXED WITH ABUNDANT ACUTE INFLAMMATION. NO PATIENT COMPLIANCE, SURGICAL TECHNIQUE, OR TREATMENT INFORMATION PROVIDED. OUTCOME WAS UNKNOWN AT TIME OF INITIAL REPORT. SURGEON REPORTED CAUSALITY TO SALES REPRESENTATIVE AS UNKNOWN. AXOGEN REPORTED CAUSALITY AS POSSIBLY RELATED. S

  Patient problems: Wound Dehiscence

  MAUDE report 23634880 ↗
• InjurySep 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2025, THE PATIENT UNDERWENT CARPAL TUNNEL REVISION SURGERY USING THE AXOGUARD HA+ NERVE PROTECTOR. THREE WEEKS POST-SURGERY, ON (B)(6) 2025, THE PATIENT CONSULTED THE SURGEON, REPORTING SYMPTOMS OF PAIN, REDNESS, AND SWELLING. THE SURGEON NOTED THAT THESE SYMPTOMS BEGAN APPROXIMATELY THREE WEEKS FOLLOWING THE PROCEDURE. UNFORTUNATELY, THERE IS A LACK OF INFORMATION REGARDING THE TREATMENT PROVIDED, PATIENT COMPLIANCE, OR THE SURGICAL TECHNIQUE USED. ON THE SAME DAY, THE SURGEON PROCEEDED TO EXPLANT THE DEVICE. SAMPLES WERE SENT FOR CULTURE AND PATHOLOGY ANALYSIS, WHICH RETURNED NEGATIVE CULTURE RESULTS. HOWEVER, THE PATHOLOGY REPORT INDICATED THE PRESENCE OF A GIANT CELL REACTION AS WELL AS LYMPHOCYTIC INFILTRATE. THE OUTCOME OF THESE EVENTS IS CURRENTLY UNDETERMINED. IN THE INITIAL REPORT, THE SURGEON DID NOT PROVIDE A CAUSALITY ASSESSMENT CONCERNING THE REPORTED EVENTS. AXOGEN HAS CLASSIFIED THE CAUSALITY AS POSSIBLY RELATED, BASED ON THE PATHOLOGY FINDINGS SUGGESTING A POTENTIAL FOREIGN BODY REACTION. NONETHELESS, CONSIDERING THE LOT ANALYSIS DATA THAT SHOWS NO OTHER COMPLAINTS OR ADVERSE EVENTS ASSOCIATED WITH THIS LOT, IT IS CONCEIVABLE THAT THIS ADVERSE EVENT MIGHT

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 22976999 ↗
• InjuryAug 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  HA+ WAS IMPLANTED ON (B)(6) 2025 TO MANAGE THE PATIENT'S DISCOMFORT FROM A PREVIOUS PALMARIS LONGUS HARVEST RELATED TO A TRAPEZIECTOMY FOR A SUSPENSION PLASTY, THE SURGEON PERFORMED AN INCISION JUST ABOVE THE WRIST. IN THIS PROCEDURE, HA+ WAS APPLIED AS AN ADHESION BARRIER TO PROTECT THE TENDONS IN THE WRIST, WHERE THE PATIENT HAD BEEN EXPERIENCING INFLAMMATION. ALTHOUGH THE USE OF HA+ ON THE TENDON WAS COMMUNICATED AS OFF-LABEL, THE SURGEON MADE A DECISION TO UTILIZE IT, DRAWING ON HIS CLINICAL EXPERTISE AND JUDGMENT FOR THE PATIENT'S BENEFIT. HOWEVER, POST-OPERATIVE COMPLICATIONS AROSE, LEADING TO AN INFECTION THAT NECESSITATED THE REMOVAL OF THE HA+ DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22749098 ↗
• InjuryMay 9, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT UNDERWENT A CUBITAL TUNNEL REVISION SURGERY TOOK PLACE ON (B)(6) 2024, WHICH INVOLVED THE IMPLANTATION OF A DEVICE. FOLLOWING THIS, THE DEVICE WAS EXPLANTED ON (B)(6) 2025. THE PATHOLOGY REPORT FROM THE EXPLANT SURGERY RULED OUT INFECTION, NOTING ONLY A FEW POLYMORPHONUCLEAR LEUKOCYTES AND NO IDENTIFIABLE ORGANISMS. THIS, ALONG WITH THE INDEPENDENT ASSESSMENTS BY BOTH THE PRIMARY SURGEON AND A CONSULTANT FROM AXOGEN, SUGGESTS THAT THERE MAY HAVE BEEN A FOREIGN BODY INFLAMMATORY REACTION RELATED TO THE IMPLANTED DEVICE. IT'S CRUCIAL TO CONSIDER THE TIMELINE SURROUNDING THE PATIENT'S CONDITION. JUST FIVE DAYS POST-SURGERY, THE PATIENT WAS INVOLVED IN A CAR ACCIDENT, WHICH NECESSITATED AN OPERATING ROOM ADMISSION AND A CHANGE IN THE INITIAL SURGICAL DRESSING. THE DRESSING WAS REPORTEDLY APPLIED TIGHTER THAN USUAL, BUT BOTH THE SURGEON AND THE PRINCIPAL INVESTIGATOR (PI) DID NOT FIND A DIRECT CORRELATION BETWEEN THE ACCIDENT AND THE POST-SURGICAL COMPLICATIONS OBSERVED. REGARDING THE POSSIBILITY OF THE OBSERVED EVENTS BEING A RESPONSE TO THE PORCINE MATERIAL OF THE DEVICE, IT CANNOT BE OUTRIGHT DISMISSED. HOWEVER, THE MRI FINDINGS SUGGESTED THAT THE NERVE APPEARED NORMAL WI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21992577 ↗
• InjuryNov 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SURGEON SUCCESSFULLY IMPLANTED THE DEVICE ON (B)(6) 2024, ALONG THE SUPERFICIAL PERONEAL NERVE IN THE PATIENT'S FOOT. HOWEVER, DURING A SUBSEQUENT POST-OPERATIVE FOLLOW-UP, THE PATIENT DEVELOPED AN INFECTION AT THE WOUND SITE. THE SURGEON NOTED PURULENCE AND OBSERVED A SMALL OBJECT PROTRUDING FROM THE WOUND, WHICH LED TO THE COMPLETE REMOVAL OF THE DEVICE ON (B)(6) 2024. AT THE TIME OF IMPLANTATION, THERE WERE NO SIGNS OF INFECTION, INDICATING THAT THE PROCEDURE WENT WELL INITIALLY. IT APPEARS THAT THE ANATOMICAL PLACEMENT OF THE DEVICE ON THE DORSUM OF THE FOOT, ALONG WITH THE LIMITED PROTECTIVE TISSUE IN THAT AREA, MAY HAVE CONTRIBUTED TO THE SUBSEQUENT WOUND DEHISCENCE AND INFECTION. NEVERTHELESS, THERE IS CURRENTLY INSUFFICIENT EVIDENCE TO ESTABLISH A DIRECT LINK BETWEEN THESE COMPLICATIONS AND THE AXOGUARD HA+NERVE PROTECTOR.

  Patient problems: Wound Dehiscence; Wound Infection

  MAUDE report 20743232 ↗