NEOVEIL NV-L-05GRecalls & 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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04548366322450), received between Dec 23, 2025 and Jan 26, 2026 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Rash2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
MFR REPORT #: 3010668881-2025-00004. A RASH DEVELOPED ON THE SKIN WHERE THE NV WAS INSERTED, MATCHING THE SHAPE OF THE NV. DURING THE RASH, THERE WAS PAIN AND A FEELING OF TIGHTNESS. APPROXIMATELY TWO WEEKS POST-SURGERY, THE SKIN WHERE THE NV WAS INSERTED BECAME RED IN THE SHAPE OF THE NV. THERE WAS NO FEVER, AND BLOOD TESTS SHOWED NO ABNORMALITIES. THE ATTENDING PHYSICIAN STATED IT WAS NOT AN INFECTION. AFTER ADMINISTERING ANTIBIOTICS FOR SEVERAL DAYS, THE REDNESS SUBSIDED, SO FOLLOW-UP WAS CONTINUED AS AN OUTPATIENT. SUBSEQUENTLY, A SECOND EPISODE OF REDNESS OCCURRED IN THE SAME AREA. TESTS WERE PERFORMED, BUT NO ABNORMALITIES WERE FOUND. THE TYPE OF ANTIBIOTIC WAS CHANGED, AND OUTPATIENT TREATMENT CONTINUES. AS OF THE OUTPATIENT VISIT ON (B)(6) 2025 (WED), THE REDNESS HAD SUBSIDED SIGNIFICANTLY, WITH ONLY ONE SMALL AREA REMAINING RED. THE PLAN IS TO CONTINUE OBSERVATION.
Patient problems: Rash
MAUDE report 24185866 ↗InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A RASH DEVELOPED ON THE SKIN WHERE THE NV WAS INSERTED, MATCHING THE SHAPE OF THE NV. DURING THE RASH, THERE WAS PAIN AND A FEELING OF TIGHTNESS. APPROXIMATELY TWO WEEKS POST-SURGERY, THE SKIN WHERE THE NV WAS INSERTED BECAME RED IN THE SHAPE OF THE NV. THERE WAS NO FEVER, AND BLOOD TESTS SHOWED NO ABNORMALITIES. THE ATTENDING PHYSICIAN STATED IT WAS NOT AN INFECTION. AFTER ADMINISTERING ANTIBIOTICS FOR SEVERAL DAYS, THE REDNESS SUBSIDED, SO FOLLOW-UP WAS CONTINUED AS AN OUTPATIENT. SUBSEQUENTLY, A SECOND EPISODE OF REDNESS OCCURRED IN THE SAME AREA. TESTS WERE PERFORMED, BUT NO ABNORMALITIES WERE FOUND. THE TYPE OF ANTIBIOTIC WAS CHANGED, AND OUTPATIENT TREATMENT CONTINUES. AS OF THE OUTPATIENT VISIT ON (B)(6) (WED), THE REDNESS HAD SUBSIDED SIGNIFICANTLY, WITH ONLY ONE SMALL AREA REMAINING RED. THE PLAN IS TO CONTINUE OBSERVATION.
Patient problems: Rash
MAUDE report 23880368 ↗
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
- GORE BIO-A Hernia Plug HP02W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, staple line reinforcement2 reports
- NEOVEIL NV-ET-M60A-2Gunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement1 report
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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