NeuraWrap® NW1040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780026402), received between Oct 2, 2024 and Oct 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K041620); 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 16, 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.

• InjuryOct 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A NURSE REPORTED A NEURAWRAP (ID: (B)(4) WAS IMPLANTED ON (B)(6) 2024. APPROXIMATELY 26 DAYS AFTER IMPLANTATION OF NEURAWRAP NERVE PROTECTOR, PATIENT DEVELOPED SYMPTOMS OF WORSENING SWELLING WITH NEUROPATHIC AND CUTANEOUS PAIN. INITIAL TREATMENT WAS MEDROL DOSEPAK WITH SYMPTOMS RETURNING AFTER TREATMENT COMPLETED. SECONDARY TREATMENT INVOLVED GABAPENTIN 100MG TID, COMPRESSION, ROM EXERCISES. NINE WEEKS FROM INITIAL SURGERY DATE, THE SYMPTOMS CONTINUED TO WORSEN, THEREFORE THE NEURAWRAP WAS REMOVED ON (B)(6) 2024. CULTURES AND SPECIMEN WERE SENT TO LABORATORY AND SHOWED A "FIBRINO-INFLAMMATORY EXUDATE" WITH CULTURES SHOWING "NO GROWTH" AT 5 DAYS. AFTER THE PRODUCT WAS REMOVED, PATIENT HAD DRAMATIC IMPROVEMENT OF SYMPTOMS. REASON FOR NEURAWRAP USE: RIGHT RECURRENT CARPAL TUNNEL SYNDROME WITH CUTANEOUS NEUROMA. THE DECISION WAS MADE TO PERFORM A NERVE WRAP TO PREVENT FURTHER SCAR ADHESIONS TO THE MEDIAN NERVE AT THE SITE OF MAXIMAL INSULT.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 20472832 ↗
• InjuryOct 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED A POSSIBLE CONTACT ALLERGY REACTION IN THE NEURAWRAP LOCATION. THE PATIENT POSSIBLY NEEDS A NEW SURGERY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20356167 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041620. One submission often covers many models, so check the product and lot details in each record.

• Z-1286-2013 · Mar 28, 2013 · Terminated
  NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.