NeuraGen® PNG230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780026464), received between Mar 30, 2022 and Dec 20, 2022 — classified as 1 injury, 1 malfunction.

2 other recalls cover devices cleared under the same FDA submission (K011168); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPORTED AN EXPIRED NEURAGEN NERVE GUIDE (ID PNG230) WAS IMPLANTED. THE EXPIRATION DATE IS SEPTEMBER 30, 2022 AND WAS IMPLANTED ON (B)(6) 2022. NO PATIENT INJURY REPORTED, AND NO MEDICAL INTERVENTION REQUIRED. NAME OF PROCEDURE: TENOLYSIS EXCISION. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE EXPIRY DATE WAS CHECKED BEFORE IT WAS INSERTED, BUT IT APPEARS THAT IT WASN¿T NOTICED THAT THE PRODUCT EXPIRED. THE PRODUCT REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019344 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 2 REPORTS. OTHER MFG REPORT NO.: 1121308-2022-00019. A FACILITY REPORTED THAT A (B)(6) MALE PATIENT WITH (PNG130) NEURAGEN NERVE GUIDE HAD TISSUE POST INFECTION. IT WAS NOTED THAT THE PATIENT HAD REDNESS, SWELLING AND PURULENT DRAINAGE OF THE HAND. NO CULTURE WAS TAKEN HOWEVER, THE INFECTION WAS TREATED WITH ORAL ANTIBIOTICS AND WOUND CARE. MEDICAL NOTES: "A (B)(6) MALE CAME TO THE CLINIC ON (B)(6) 2021, REQUESTING TO BE SEEN DUE TO CONCERNS FOR INFECTION TO HIS HAND. HE IS 5 WEEKS OUT FROM ZONE 2 FDS/FDP REPAIR TO RIGHT INDEX, MIDDLE AND RING FINGER. HE HAS BEEN WORKING WITH THERAPY. HE REPORTS CONCERNS FOR REDNESS, SWELLING AND PURULENT DRAINAGE. HE OCCASIONALLY NOTICES A MALODOR. HE WAS SEEN BY THE HAND SURGERY PA AND GIVEN 1 WEEK PRESCRIPTION FOR CLINDAMYCIN. PAIN IS ACTUAL AND SUSPECTED WITH NUMERIC PAIN SCORE OF 4. ON THE EXAMINATION OF RIGHT HAND, SKIN SURROUNDING SURGICAL SCAR IS PINK/ERYTHEMATOUS. THERE IS OPEN WOUND UNDERLYING THE RING FINGER PROXIMAL PHALANX APPROXIMATELY 2 X 2 CM WHICH HAS A SMALL AREA OF NECROTIC TISSUE CENTRALLY. THERE IS SOME SLOUGH SURROUNDING THIS BUT NO FRANK PURULENCE. NO MALODOR NOR FLUCTUANCE. NO TENDERNESS HOWEVER PATIENT IS NUMB

  Patient problems: Purulent Discharge; Skin Infection; Swelling/ Edema

  MAUDE report 13952018 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011168. One submission often covers many models, so check the product and lot details in each record.

• Z-1470-2020 · Feb 7, 2020 · Terminated
  NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap cl
• Z-1287-2013 · Mar 28, 2013 · Terminated
  NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.