Skip to content

NeuroFlex CNCF3025Recalls & reported problems

Collagen Matrix, Inc. · Flexible Collagen Nerve Cuff 3mm (inner diameter) x 2.5cm (length) · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954020082), received between Jan 30, 2016 and Jan 30, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 30, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    PRIOR TO DEVICE USE, AND AFTER THE PRODUCT (3.0MM X 2.5CM NEUROFLEX TUBE) WAS PREPARED/HYDRATED FOR USE, A TECHNICIAN NOTICED THAT THE DEVICE FELT HARD IN THE MIDDLE. THE SURGEON FELT THE DEVICE AND OBSERVED THAT THERE SEEMED TO BE A HARD PLASTIC TUBE INSIDE THE PRODUCT. THE DEVICE WAS DISCARDED AND A NEW 2.5MM X 2.5CM DEVICE WAS USED INSTEAD. THE PRODUCT IN QUESTION WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5400133 ↗

Other Cuff, Nerve devices

All Cuff, Nerve devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.