NervAlign Nerve Cuff NA-NC3040Recalls & reported problems
Renerve Limited · An absorbable collagen membrane implant that provides non-constricting protection for peripheral nerves. It is designed to be an interface between the nerve and the surrounding tissue and used for the repair of peripheral nerves in which there is no gap or where a gap closure is achieved by flexion of the extremity. · Class 2 · Implant
Data updated Oct 18, 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 09369998231904), received between Jan 28, 2026 and Jan 28, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection1
Patient problems
- Abnormal scarring1
- Implant Pain1
- Sinusitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2026Device Appears to Trigger Rejection
THE SURGEON IMPLANTED A 30X40MM NERVALIGN NERVE CUFF ON (B)(6) 2025 AND THE PATIENT DID NOT IMMEDIATELY REPORT ANY ISSUES POST-OPERATIVELY. THE SURGEON DID NOT SEE THE PATIENT AGAIN UNTIL APPROXIMATELY ON (B)(6) 2025 (~5 MONTHS), THE PATIENT REPORTED SIGNIFICANT PAIN AND PRESENTED WITH HYPERTROPHIC SCARS. THE SURGEON REVISION PROCEDURE ON (B)(6) 2025 WAS TO ADDRESS NERVE ENTRAPMENT PRESUMED TO BE FROM A PREVIOUS SURGERY, WHICH HE DID NOT PERFORM. THE SURGEON CUT THE 30X40MM CUFF IN HALF AND USED THE MATERIAL IN BOTH PLACES WHERE CUTANEOUS SCARRING PRESENTS. NOTE: THE NERVE CUFF IS ALSO PROVIDED IN 10MMX10MM SIZE, USING MEMBRANES CUT INTO HALF IS NOT EXPECTED TO BE PROBLEMATIC. THE LINEAR INCISION (FULLY HEALED AND JUST BEHIND THE MALLEOLUS) FROM THE FIRST SURGERY IS OBSERVABLE AT THE PATIENT'S POSTEROLATERAL ANKLE. THE SURGEON SHARED THAT HIS PATIENT DOES HAVE ABNORMAL SENSITIVITIES / MEDICATION ALLERGIES TO ESTRADIOL AND NORELGESTROMIN. NO PREVIOUS KELOID FORMATION WAS OBSERVED FOLLOWING THE PRIMARY PROCEDURE, AND THE PATIENT DID NOT SHARE ANY KNOWN SENSITIVITY TO PORCINE MATERIALS. SINCE THE PATIENT CONTINUES TO EXPERIENCE INTERMITTENT SWELLING AND IS 5-MONTHS POST-OP, THE SURGEO
Patient problems: Abnormal scarring; Implant Pain; Sinusitis
MAUDE report 24197164 ↗
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
- VersaWrap VTP-2201Alafair Biosciences, Inc. · Cuff, Nerve2 reports
- NeuraWrap® NW1040Integra Lifesciences Corporation · CUFF, NERVE2 reports
- NeuraGen® PNG230Integra Lifesciences Corporation · CUFF, NERVE2 reports
- NeuraGen® PNG630Integra Lifesciences Corporation · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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