Axoguard HA+ Nerve Protector AGHA24Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850828007121), received between Nov 12, 2024 and Apr 3, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  THIS IS AN INITIAL, SERIOUS, SPONTANEOUS REPORT RECEIVED FROM A SALES REPRESENTATIVE VIA SURGEON REGARDING A PATIENT WHO UNDERWENT TARSAL TUNNEL DECOMPRESSION IN WHICH AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED AND EXPERIENCED PURULENT DISCHARGE. ON (B)(6) 2025, THE PATIENT UNDERWENT A TARSAL TUNNEL DECOMPRESSION WHERE AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED. THE SURGEON LAID THE HA+ FLAT OVER THE NERVE AND DID NOT SUTURE IT IN PLACE. IN (B)(6) 2026, THE SURGEON WAS MADE AWARE OF CONCERNS FOR A POSSIBLE INFECTION WITH PURULENT DISCHARGE AT THE SURGICAL SITE. DURING EXPLANTATION, THE WRAP FELL APART INTO TWO PIECES AND THE SURGEON NOTED THAT IT ALMOST LOOKED LIKE HA+ WAS EXTRUDING, AS THE MATERIAL WAS LOCATED CLOSE TO THE INCISION SITE UPON OPENING. THE SURGEON CLEANED THE SITE AND PERFORMED CLOSURE IN THE CLINIC.

  Patient problems: Purulent Discharge

  MAUDE report 24780735 ↗
• InjuryFeb 15, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, FEMALE PATIENT UNDERWENT CARPAL TUNNEL REVISION SURGERY. AT THE ONE-WEEK POST-OP APPOINTMENT, PATIENT HAD REDNESS AT THE INCISION SITE. SURGEON PUT PATIENT ON A FEW DAYS OF DOXYCYCLINE. AT THE TWO-WEEK POST-OP APPOINTMENT, PATIENT HAD WORSENING REDNESS AND PAIN AT THE SITE. SURGEON TOOK PATIENT BACK TO THE OR, IRRIGATED THE SITE, AND NOTICED THE HA+ PROTECTOR LOOKED LIKE A PIECE OF FATTY COLLAGEN. THE HA+ PROTECTOR WAS EXPLANTED AND FELL APART IN TWO PIECES. THE SURGEON HAD CULTURES SENT WHICH WERE NEGATIVE FOR INFECTION, DID NOT SEND FOR PATHOLOGY. SINCE THE HA+ PROTECTOR WAS EXPLANTED, EVENTS HAVE RESOLVED. NO CAUSALITY WAS REPORTED, THOUGH THE SURGEON REMARKED THAT THE PATIENT MAY HAVE NOT TOLERATED THE DEVICE. AXOGEN ASSESSED CAUSALITY AS POSSIBLY RELATED. CULTURES OBTAINED DURING EVALUATION WERE NEGATIVE, AND NO PATHOLOGY WAS PERFORMED, LIMITING THE ABILITY TO DETERMINE THE UNDERLYING CAUSE OF THE REPORTED REDNESS AND PAIN.

  Patient problems: Erythema; Pain

  MAUDE report 24341672 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2025, PATIENT UNDERWENT A CARPAL TUNNEL REVISION WITH AXOGUARD HA+ (LOT UNKNOWN TO REP; FOUND WITH INTERNAL RECORDS AS LB1620172) IMPLANTATION. ON (B)(6) 2025, PATIENT UNDERWENT THIRD CARPAL TUNNEL REVISION WITH A POSSIBLE NEUROMA EXCISION. SURGEON DID NOT FIND ANY NERVE DAMAGE OR NEUROMA, INSTEAD THERE WAS ONLY HYPERSENSITIVITY AROUND THE SURGICAL SITE. DURING 27-OCT SURGERY, SURGEON PULLED OUT A PIECE OF FATTY TISSUE BUT DID NOT EXPLANT THE HA+. NO CULTURES/PATHOLOGY REPORTED. NO TREATMENT INFORMATION, SURGICAL TECHNIQUE, OR OUTCOMES REPORTED. SURGEON REPORTED CAUSALITY AS POSSIBLY RELATED. AXOGEN REPORTED CAUSALITY AS UNASSESSABLE. BASED ON THE LIMITED INFORMATION AND NO CUTLURES/PATHOLOGY REPORTS, IT IS IMPOSSIBLE TO MAKE A FIRM CONCLUSION. WE ARE UNABLE TO DETERMINE IF OTHER FACTORS, SUCH AS SURGICAL TECHNIQUE, COMORBIDITIES, OR POST-OPERATIVE CARE CONTRIBUTED TO THIS OUTCOME.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23646409 ↗
• InjuryJul 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED A COMPLETE LOSS OF SENSATION ON THE LEFT SIDE OF THEIR HAND THREE WEEKS FOLLOWING A PRC SURGERY, WHICH OCCURRED PRIOR TO THE IMPLANTATION OF THE AXOGUARD HA+. UPON FURTHER EXAMINATION, THE PATIENT WAS DIAGNOSED WITH MEDIAN NERVE ENTRAPMENT ASSOCIATED WITH CARPAL TUNNEL SYNDROME. THE AXOGUARD HA+ WAS SUBSEQUENTLY IMPLANTED DURING A CARPAL TUNNEL SURGERY APPROXIMATELY 2.5 MONTHS AGO, WITH THE SPECIFIC DATE RECORDED AS (B)(6) 2025. AFTER THE CARPAL TUNNEL AND AXOGUARD HA+ IMPLANTATION PROCEDURE, THE SURGICAL WOUND EXPERIENCED CHALLENGES IN HEALING EFFECTIVELY FOR A PERIOD OF ABOUT THREE WEEKS. ULTIMATELY, THE DEVICE WAS EXPLANTED DURING A REVISION SURGERY AT AN UNSPECIFIED DATE THEREAFTER. THE REVISION SURGERY LIKELY INVOLVED THE REMOVAL OF PART OR ALL OF THE AXOGUARD HA+ IMPLANT. DURING THIS PROCEDURE, THE SURGEON UTILIZED A TOURNIQUET ON THE AFFECTED ARM AND RE-CLOSED THE WOUND. SINCE THE REVISION, THE PATIENT HAS REPORTED ONGOING AND PROGRESSIVELY WORSENING NUMBNESS IN THE HAND, WHICH HAS RESULTED IN MUSCLE ATROPHY AND SIGNIFICANT SCARRING AROUND THE SURGICAL SITE. THE PATIENT HAS INDICATED THAT, DESPITE LOCAL WOUND CARE SUPPORT AND THE USE OF STERI-STRIPS, THE

  Patient problems: Impaired Healing; Muscle Weakness/Atrophy; Numbness

  MAUDE report 22663082 ↗
• InjuryNov 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A REVISION CARPAL TUNNEL RELEASE SURGERY ON (B)(6) 2024, DURING WHICH AN AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED. THE PATIENT WAS REPORTED DOING WELL DURING HER FOLLOW-UP VISIT, WITH STITCHES BEING REMOVED ON (B)(6) 2024. HOWEVER, SHORTLY AFTER, SHE EXPERIENCED DEHISCENCE OF THE PROXIMAL WOUND AND RETURNED TO THE CLINIC ON (B)(6) 2024 FOR EVALUATION. ON (B)(6) 2024, THE PATIENT UNDERWENT A DRAINAGE AND WASHOUT OF THE WOUND FOR A SUSPECTED INFECTION AND IT WAS CONFIRMED AT THAT TIME THAT THE PROTECTIVE COVERING REMAINED INTACT, HOWEVER THE AXOGUARD HA+ NERVE PROTECTOR WAS PROPHYLACTICALLY REMOVED TO ELIMINATE ANY POTENTIAL RISKS FROM A FOREIGN BODY IN AN INFECTED FIELD. A CULTURE TAKEN FROM THE FLUID IN THE WOUND IDENTIFIED ENTEROBACTER CLOACAE. CONSIDERING THE DEVICE WAS INTACT THROUGHOUT THE POSTOPERATIVE PERIOD, IT IS HIGHLY UNLIKELY THAT IT CONTRIBUTED TO THE WOUND COMPLICATION.

  Patient problems: Bacterial Infection

  MAUDE report 20666085 ↗