NeuraWrap® NW1020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780071808), received between Jan 27, 2023 and Jan 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED INFLAMMATION AND SUSPECTED HYPERSENSITIVITY TO NEURAWRAP. PATIENT HAD NEURAWRAP NERVE PROTECTOR INSERTED ON (B)(6) 2019.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 16257710 ↗

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.