NEOVEIL NV-M-015GRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04548366322528), received between Dec 23, 2025 and Jan 26, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination 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
- Adverse Event Without Identified Device or Use Problem2
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- Fungal Infection2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Contamination /Decontamination Problem
MFR REPORT #: 3010668881-2025-00006. A NEEDLE-LIKE FOREIGN OBJECT WAS IDENTIFIED BY THE ATTENDING PHYSICIAN IN A CASE INVOLVING THE USE OF NV SHEET. THE NEEDLE-LIKE FOREIGN OBJECT WAS DISCOVERED WHEN THE ATTENDING PHYSICIAN EXAMINED THE NV SHEET THAT HAD BEEN OPENED BY A NURSE AND PLACED IN A PETRI DISH. THE FOREIGN OBJECT WAS REMOVED FROM THE NV SHEET, AND THE SHEET WAS USED AS INTENDED. THERE WAS NO HEALTH INJURIES TO THE PATIENT AND NO SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185994 ↗InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
MFR REPORT #: 3010668881-2025-00005. THE PRODUCT WAS USED IN A CASE AT (B)(6) HOSPITAL. THE FIRST CASE INVOLVED A RIGHT UPPER LOBECTOMY IN 2019, WHERE THE PRODUCT WAS DIVIDED INTO 8-12 PIECES AND PLACED IN THE RIGHT MIDDLE LOBE FOLLOWING THE RIGHT UPPER LOBECTOMY. TWO YEARS AFTER THE FIRST CASE, FUNGAL INFECTION WAS OBSERVED, AND RE-THORACOTOMY WAS PERFORMED IN 2021. (SURGICAL INTERVENTION WAS PERFORMED AS ORAL MEDICATION DID NOT RESULT IN IMPROVEMENT.) DURING THE RE-THORACOTOMY, IT WAS CONFIRMED THAT THE PRODUCT REMAINED IN THE BODY. THE RETAINED CONDITION WAS ALMOST THE SAME AS AT THE TIME OF PLACEMENT, AND IT WAS IMMEDIATELY IDENTIFIABLE AS THE PRODUCT. A 2-3 MM MEMBRANE HAD FORMED AROUND THE PRODUCT, AND FUNGUS WAS CONFIRMED THROUGHOUT THE LUNG, RAISING CONCERNS THAT THE PRODUCT MAY HAVE BECOME A SOURCE OF INFECTION AND FUNGAL GROWTH. THE PRODUCT WAS REMOVED AS MUCH AS POSSIBLE, AND THERE WERE NO ISSUES WITH THE PATIENT'S PROGNOSIS. 2019: USED IN SURGERY. 2021: THORACOTOMY PERFORMED DUE TO FUNGAL INFECTION, TWO YEARS AFTER THE FIRST USE. 2025: ON AUGUST 8, DURING A PRESENTATION AT THE FACILITY, DR. (B)(6) SHARED INFORMATION ABOUT THIS CASE AND RAISED QUESTIONS.
Patient problems: Fungal Infection
MAUDE report 24185948 ↗MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NEEDLE-LIKE FOREIGN OBJECT WAS IDENTIFIED BY THE ATTENDING PHYSICIAN IN A CASE INVOLVING THE USE OF NV SHEET. THE NEEDLE-LIKE FOREIGN OBJECT WAS DISCOVERED WHEN THE ATTENDING PHYSICIAN EXAMINED THE NV SHEET THAT HAD BEEN OPENED BY A NURSE AND PLACED IN A PETRI DISH. THE FOREIGN OBJECT WAS REMOVED FROM THE NV SHEET, AND THE SHEET WAS USED AS INTENDED. THERE WAS NO HEALTH INJURIES TO THE PATIENT AND NO SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881810 ↗InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRODUCT WAS USED IN A CASE AT (B)(6) HOSPITAL. THE FIRST CASE INVOLVED A RIGHT UPPER LOBECTOMY IN 2019, WHERE THE PRODUCT WAS DIVIDED INTO 8-12 PIECES AND PLACED IN THE RIGHT MIDDLE LOBE FOLLOWING THE RIGHT UPPER LOBECTOMY. TWO YEARS AFTER THE FIRST CASE, FUNGAL INFECTION WAS OBSERVED, AND RE-THORACOTOMY WAS PERFORMED IN 2021. (SURGICAL INTERVENTION WAS PERFORMED AS ORAL MEDICATION DID NOT RESULT IN IMPROVEMENT.) DURING THE RE-THORACOTOMY, IT WAS CONFIRMED THAT THE PRODUCT REMAINED IN THE BODY. THE RETAINED CONDITION WAS ALMOST THE SAME AS AT THE TIME OF PLACEMENT, AND IT WAS IMMEDIATELY IDENTIFIABLE AS THE PRODUCT. A 2-3 MM MEMBRANE HAD FORMED AROUND THE PRODUCT, AND FUNGUS WAS CONFIRMED THROUGHOUT THE LUNG, RAISING CONCERNS THAT THE PRODUCT MAY HAVE BECOME A SOURCE OF INFECTION AND FUNGAL GROWTH. THE PRODUCT WAS REMOVED AS MUCH AS POSSIBLE, AND THERE WERE NO ISSUES WITH THE PATIENT'S PROGNOSIS. 2019: USED IN SURGERY 2021: THORACOTOMY PERFORMED DUE TO FUNGAL INFECTION, TWO YEARS AFTER THE FIRST USE 2025: ON (B)(6), DURING A PRESENTATION AT THE FACILITY, DR. (B)(6) INFORMATION ABOUT THIS CASE AND RAISED QUESTIONS.
Patient problems: Fungal Infection
MAUDE report 23881192 ↗
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-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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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