NEOVEIL NV-L-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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04548366322481), received between Mar 31, 2025 and May 31, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).
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
- Device Appears to Trigger Rejection2
- Patient Device Interaction Problem2
- Insufficient Device Problem Information1
Patient problems
- Adhesion(s)2
- Scar Tissue2
- Anaphylactic Shock1
- Failure to Anastomose1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2026Insufficient Device Problem Information
MFR REPORT #: 3010668881-2026-00002. AN ANASTOMOTIC LEAK OCCURRED.
Patient problems: Failure to Anastomose
MAUDE report 25345058 ↗InjuryOct 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MFR REPORT #: 3010668881-2025-00002. A CHEST CT SCAN WAS PERFORMED SEVERAL DAYS POSTOPERATIVELY FOR FOLLOW-UP IN A PATIENT TREATED WITH NV AND BOLHEAL. THE SCAN REVEALED EXTENSIVE ADHESIONS THROUGHOUT THE PLEURAL CAVITY. THE ATTENDING PHYSICIAN INQUIRED WITH THE SALES REPRESENTATIVE ABOUT WHY EXTENSIVE ADHESIONS HAD DEVELOPED DESPITE TARGETING LOCALIZED INFLAMMATORY RESPONSE AT SPECIFIC APPLICATION SITES. IN RESPONSE TO THE SALES REPRESENTATIVE'S ANSWER, THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION THAT THE POSSIBILITY OF ANAPHYLACTIC SHOCK DUE TO FIBRIN GLUE HAD BEEN OVERLOOKED. THE PATIENT EXPERIENCED SIGNIFICANT HYPOTENSION AND MILD SHOCK SYMPTOMS POSTOPERATIVELY, WHICH WERE STABILIZED WITH NOREPINEPHRINE ADMINISTRATION. THE DRAIN WAS SUBSEQUENTLY REMOVED. NO PLEURAL EFFUSION WAS OBSERVED, AND THE CLINICAL COURSE HAS BEEN FAVORABLE. MANAGEMENT OF ASCITES IS PLANNED GOING FORWARD.
Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction
MAUDE report 23275793 ↗InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A CHEST CT SCAN WAS PERFORMED SEVERAL DAYS POSTOPERATIVELY FOR FOLLOW-UP IN A PATIENT TREATED WITH NV AND BOLHEAL. THE SCAN REVEALED EXTENSIVE ADHESIONS THROUGHOUT THE PLEURAL CAVITY. THE ATTENDING PHYSICIAN INQUIRED WITH THE SALES REPRESENTATIVE ABOUT WHY EXTENSIVE ADHESIONS HAD DEVELOPED DESPITE TARGETING LOCALIZED INFLAMMATORY RESPONSE AT SPECIFIC APPLICATION SITES. IN RESPONSE TO THE SALES REPRESENTATIVE'S ANSWER, THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION THAT THE POSSIBILITY OF ANAPHYLACTIC SHOCK DUE TO FIBRIN GLUE HAD BEEN OVERLOOKED. THE PATIENT EXPERIENCED SIGNIFICANT HYPOTENSION AND MILD SHOCK SYMPTOMS POSTOPERATIVELY, WHICH WERE STABILIZED WITH NOREPINEPHRINE ADMINISTRATION. THE DRAIN WAS SUBSEQUENTLY REMOVED. NO PLEURAL EFFUSION WAS OBSERVED, AND THE CLINICAL COURSE HAS BEEN FAVORABLE. MANAGEMENT OF ASCITES IS PLANNED GOING FORWARD.
Patient problems: Adhesion(s); Anaphylactic Shock
MAUDE report 23075948 ↗InjuryJun 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MFR REPORT #: 3010668881-2025-00001 NEOVEIL (SHEET) WAS USED TO PREVENT PANCREATIC FLUID LEAKAGE DURING A LYMPH NODE DISSECTION PERFORMED AS PART OF A GASTRECTOMY FOR ADVANCED GASTRIC CANCER ON (B)(6) 2024. POSTOPERATIVELY, THERE WAS NO PANCREATIC LEAKAGE, AND THE PATIENT WAS DISCHARGED SOON THEREAFTER. APPROXIMATELY SIX MONTHS AFTER DISCHARGE (B)(6) 2025), THE PATIENT WAS BROUGHT IN FOR A MYOCARDIAL INFARCTION. A CT SCAN REVEALED A MASS-LIKE LESION IN THE AREA WHERE THE LYMPH NODE DISSECTION HAD BEEN PERFORMED. THE LESION WAS SURGICALLY REMOVED AND SENT FOR PATHOLOGICAL EXAMINATION. THE FINAL REPORT SUGGESTED THAT THE TISSUE WAS GRANULATION TISSUE DERIVED FROM NEOVEIL (SHEET) AND HAD BECOME EXTREMELY FIRM - LIKELY SCAR TISSUE, ACCORDING TO THE ATTENDING PHYSICIAN. CORRECTION MADE ON JUNE 3 AFTER A COMMUNICATION BY THE MANUFACTURER THAT AFTER DISCHARGE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A "CEREBRAL INFARCTION" NOT A MYOCARDIAL INFARCTION AS INITIALLY REPORTED.
Patient problems: Scar Tissue
MAUDE report 22131254 ↗InjuryMar 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
NEOVEIL (SHEET) WAS USED TO PREVENT PANCREATIC FLUID LEAKAGE DURING A LYMPH NODE DISSECTION PERFORMED AS PART OF A GASTRECTOMY FOR ADVANCED GASTRIC CANCER ON (B)(6) 2024. POSTOPERATIVELY, THERE WAS NO PANCREATIC LEAKAGE, AND THE PATIENT WAS DISCHARGED SOON THEREAFTER. APPROXIMATELY SIX MONTHS AFTER DISCHARGE ((B)(6) 2025), THE PATIENT WAS BROUGHT IN FOR A MYOCARDIAL INFARCTION. A CT SCAN REVEALED A MASS-LIKE LESION IN THE AREA WHERE THE LYMPH NODE DISSECTION HAD BEEN PERFORMED. THE LESION WAS SURGICALLY REMOVED AND SENT FOR PATHOLOGICAL EXAMINATION. THE FINAL REPORT SUGGESTED THAT THE TISSUE WAS GRANULATION TISSUE DERIVED FROM NEOVEIL (SHEET) AND HAD BECOME EXTREMELY FIRM - LIKELY SCAR TISSUE, ACCORDING TO THE ATTENDING PHYSICIAN.
Patient problems: Scar Tissue
MAUDE report 21732208 ↗
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-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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page