NEUROCAP 2.5 mmRecalls & reported problems
Polyganics Innovations B.V. · 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 08717703990256), received between Aug 14, 2019 and Aug 14, 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
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A RIGHT SAPHENOUS NEURECTOMY WITH 3 NEUROCAPS INSERTED AT HIS INITIAL SURGERY ON (B)(6) 2018. HE DEVELOPED THE RECURRENCE OF A NEUROMA WHICH REQUIRED A SECOND OPERATION TO EXCISE THE NEUROMA.
Patient problems: No Code Available
MAUDE report 8891880 ↗
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
- NeuroMend CNW12025Collagen Matrix, Inc. · Cuff, Nerve1 report
- NervAlign Nerve Cuff NA-NC3040Renerve Limited · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page