NEOVEIL NV-ET-M60A-2Recalls & reported problems
Gunze Limited · As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2). · 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 04547301462534), received between May 31, 2026 and May 31, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2026Material Integrity Problem
A CUSTOMERS USES NEOVEIL TUBES IN BARIATRIC SURGERY. HE RECENTLY TESTED REFERENCE NV-ET-M60A-2 WITH GOLD PANTHER STAPLERS CADF-60S (GOLD). DURING STAPLING, A WIRE BROKE, AND ONE OF THE WHITE PARTS REMAINED SEWN TO THE BLUE PART. THE SURGEON CUT THE WHITE PART TO REMOVE IT, BUT A SMALL FRAGMENT WAS LEFT IN THE PATIENT. BASED ON OUR OBSERVATIONS, THIS ISSUE MAY BE DUE TO A CERTAIN FRAGILITY OF THE NV TUBE WIRES.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 25344872 ↗
Other Mesh, Surgical, Absorbable, Staple Line Reinforcement devices
- ECHLEON ECH60REthicon Endo-Surgery, LLC · Mesh, surgical, absorbable, staple line reinforcement313 reports
- GORE BIO-A Tissue Reinforcement FS0915W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, staple line reinforcement12 reports
- NEOVEIL NV-L-015GGunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement5 reports
- NEOVEIL NV-M-015GGunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement4 reports
- NEOVEIL NV-L-05GGunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement2 reports
- GORE BIO-A Hernia Plug HP02W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, staple line reinforcement2 reports
- GORE BIO-A Tissue Reinforcement FS1030W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, staple line reinforcement1 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.
How reports and recalls are matched · Editorial policy · Report an error on this page