NeuraGen® PNG630Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780026525), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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

• MalfunctionApr 22, 2024Use of Device Problem; Use of Device Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153645 ↗

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.