NEUROCAP 1.5 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 08717703990232), received between May 11, 2017 and May 11, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Disintegration” (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 16, 2026.
Most reported problems
Device problems
- Material Disintegration1
Patient problems
- Seroma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2017Material Disintegration
SEVERE SEROMA FORMATION AT LOCATION DISSOLVING NEUROCAP.
Patient problems: Seroma
MAUDE report 6559665 ↗
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.
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