NeuroMend CNW12025Recalls & reported problems
Collagen Matrix, Inc. · Collagen Nerve Wrap 12mm (inner diameter) x 2.5cm (length) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954020143), received between Jan 2, 2019 and Jan 2, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inflammation1
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FOLLOWING INITIAL PROCEDURE THE PATIENT COMPLAINED OF REDNESS AND SWELLING. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO PERFORM DRAINAGE, DEBRIDEMENT AND PARTIAL REMOVAL OF THE DEVICE. NO ADDITIONAL ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT HAVE BEEN REPORTED TO DATE.
Patient problems: Inflammation; Skin Irritation
MAUDE report 8209441 ↗
Other Cuff, Nerve devices
- Axoguard HA+ Nerve Protector AGHA36Axogen Corporation · Cuff, Nerve13 reports
- Axoguard HA+ Nerve Protector AGHA48Axogen Corporation · Cuff, Nerve6 reports
- Axoguard HA+ Nerve Protector AGHA24Axogen Corporation · Cuff, Nerve5 reports
- NeuraWrap® NW1040Integra Lifesciences Corporation · CUFF, NERVE2 reports
- VersaWrap VTP-2201Alafair Biosciences, Inc. · Cuff, Nerve2 reports
- NeuraGen® PNG230Integra Lifesciences Corporation · CUFF, NERVE2 reports
- NervAlign Nerve Cuff NA-NC3040Renerve Limited · Cuff, Nerve1 report
- NeuroMend CNW12050Collagen Matrix, Inc. · Cuff, Nerve1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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