C-QURRecalls & reported problems across all models
Atrium Medical Corporation · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 157
- Deaths reported
- 0
- Injuries reported
- 155
- Recalls
- 0
We found 18 models of C-QUR by Atrium Medical Corporation in the FDA's device registry (GUDID). Together they are named in 157 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2014 and Jul 24, 2025 — classified as 155 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported C-QUR problems
Device problems
- Appropriate Device Problem Term/Code Not Available60
- Adverse Event Without Identified Device or Use Problem46
- Patient-Device Incompatibility36
- Insufficient Device Problem Information11
- Material Deformation4
- Therapeutic or Diagnostic Output Failure4
- Migration or Expulsion of Device3
- Device Operates Differently Than Expected2
Patient problems
- Adhesion(s)88
- Hernia69
- Pain66
- Unspecified Infection35
- Abscess23
- Obstruction/Occlusion16
- Insufficient Information11
- Inflammation10
C-QUR models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- C-QUR 31528Mesh, surgical, polymeric34 reports
- C-QUR 31533Mesh, surgical, polymeric27 reports
- C-QUR 31544Mesh, surgical, polymeric20 reports
- C-QUR 31536Mesh, surgical, polymeric18 reports
- C-QUR 31328Mesh, surgical, polymeric11 reports
- C-QUR 31537Mesh, surgical, polymeric8 reports
- C-QUR 31543Mesh, surgical, polymeric8 reports
- C-QUR 31540Mesh, surgical, polymeric6 reports
- C-QUR 31526Mesh, surgical, polymeric4 reports
- C-QUR 31531Mesh, surgical, polymeric4 reports
- C-QUR 31332Mesh, surgical, polymeric3 reports
- C-QUR 31506Mesh, surgical, polymeric3 reports
- C-QUR 31542Mesh, surgical, polymeric3 reports
- C-QUR 31505Mesh, surgical, polymeric2 reports
- C-QUR 31507Mesh, surgical, polymeric2 reports
- C-QUR 31535Mesh, surgical, polymeric2 reports
- C-QUR 31312Mesh, surgical, polymeric1 report
- C-QUR 31326Mesh, surgical, polymeric1 report
Recent C-QUR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF WAS IMPLANTED WITH AN C-QUR MESH. PLAINTIFF ALLEGEDLY EXPERIENCED INFECTED MESH AND COLOCUTANEOUS FISTULA, ERYTHEMA, DRAINAGE, ABSCESS, PARTIAL COLECTOMY. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Fistula; Unspecified Infection
MAUDE report 22585295 ↗InjuryJul 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF WAS IMPLANTED WITH AN C-QUR MESH. PLAINTIFF ALLEGEDLY EXPERIENCED ABSCESS, DEBRIDEMENT, PURULENCE, SMALL BOWEL ADHESIONS / ADHESIOLYSIS, STRANGULATED NECROTIC BOWEL, SMALL BOWEL RESECTION, INCIDENTAL APPENDECTOMY. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Abscess; Adhesion(s)
MAUDE report 22585245 ↗InjuryJul 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF WAS IMPLANTED WITH AN C-QUR MESH. PLAINTIFF ALLEGEDLY EXPERIENCED RECURRENT VENTRAL INCISIONAL HERNIA. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION. NOTE: IMPLANT WAS CLASSIFIED AS "COMPLEX."
Patient problems: Hernia
MAUDE report 22563274 ↗InjuryJul 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF WAS IMPLANTED WITH AN C-QUR LITE MESH. PLAINTIFF ALLEGEDLY EXPERIENCED HARD PAINFUL LUMP AT HIS UMBILICUS ASSOCIATED WITH BLOATING, PAIN, NAUSEA, INABILITY TO PASS GAS, RECURRENT VENTRAL HERNIA, INCARCERATED, LLEOSTOMY SITE HERNIA- RIGHT RECTUS, PARTIAL BOWEL OBSTRUCTION, ADHESIONS. PARTIAL MESH EXPLANTED SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Adhesion(s); Hernia; Nausea; Obstruction/Occlusion; Pain
MAUDE report 22563273 ↗InjuryNov 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED THE PLAINTIFF ALSO ALLEGEDLY EXPERIENCED FOREIGN BODY RESPONSE, REJECTION, INFECTION, FAILURE OF INCORPORATION/INGROWTH, SCARIFICATION, IMPROPER WOUND HEALING, EXCESSIVE AND CHRONIC, INFLAMMATION, ALLERGIC REACTION, EROSION, ABSCESS, FISTULA, GRANULOMATOUS RESPONSE, SEROMA FORMATION AND TISSUE DAMAGE.
Patient problems: Adhesion(s); Hernia; Pain; Skin Inflammation/ Irritation
MAUDE report 20741578 ↗InjuryNov 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED THE PLAINTIFF ALSO ALLEGEDLY EXPERIENCED CHRONIC PAIN, RECURRENCE OF HERNIA, FOREIGN BODY RESPONSE, REJECTION, INFECTION, FAILURE OF INCORPORATION/INGROWTH, SCARIFICATION, IMPROPER WOUND HEALING, EXCESSIVE AND CHRONIC INFLAMMATION, ALLERGIC REACTION, EROSION, ABSCESS, FISTULA, GRANULOMATOUS RESPONSE, SEROMA FORMATION, AND TISSUE DAMAGE.
Patient problems: Adhesion(s); Bowel Burn; Pain; Skin Inflammation/ Irritation
MAUDE report 20733650 ↗InjuryNov 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED THE PLAINTIFF ALSO ALLEGEDLY EXPERIENCED RECURRENCE OF HERNIA, FOREIGN BODY RESPONSE, REJECTION, INFECTION, FAILURE OF INCORPORATION/INGROWTH, SCARIFICATION, IMPROPER WOUND HEALING, EXCESSIVE AND CHRONIC INFLAMMATION, ALLERGIC REACTION, EROSION, ABSCESS, FISTULA, GRANULOMATOUS RESPONSE, SEROMA FORMATION, AND TISSUE DAMAGE.
Patient problems: Adhesion(s); Constipation; Pain; Skin Inflammation/ Irritation
MAUDE report 20718214 ↗InjuryNov 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PLAINTIFF ALSO EXPERIENCED ABDOMINAL PAIN, OBSTRUCTIVE UMBILICAL HERNIA, TWISTED LOOP OF BOWEL THAT WAS SUCCESSFULLY REDUCED, PERIUMBILICAL VENTRAL HERNIA, INEFFECTIVE MESH, ORGAN PERFORATION, FAILED GRAFT INCORPORATION, BLEEDING, TWISTED MESH, EMOTIONAL/PSYCHOLOGICAL INJURIES, NORMOCYTIC ANEMIA DUE TO SURGICAL BLOOD LOSS, BLOOD TRANSFUSION. EXPLORATORY LAPAROTOMY, PARTIAL OMENTECTOMY, EXCISION OF SKIN AND SOFT TISSUE TYPE OF SURGERY WAS CONDUCTED.
Patient problems: Abdominal Pain; Adhesion(s); Anemia; Internal Organ Perforation; Obstruction/Occlusion
MAUDE report 20652749 ↗InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
PLAINTIFF'S ALLEGEDLY ALSO EXPERIENCED PAIN, FISTULA, HERNIA RECURRENCE, CELLULITIS, NON-INCORPORATED AND INCORPORATED MESH, EMOTIONAL INJURY, RESECTION OF DRAINING SINUS, FAILED ANTIBIOTIC THERAPY, DEBRIDEMENT, FLUID COLLECTION AND DRAINAGE.
Patient problems: Abscess; Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 20652722 ↗InjuryOct 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, INFECTED MESH AND BOWL, BOWL OBSTRUCTION, ADHESIONS, LYSIS OF ADHESIONS, LACK OF INCORPORATION, BOWEL RESECTION, ENTEROCUTANEOUS FISTULA, LOOPS OF SMALL BOWEL, DRAINING WOUND, WOUND VAC, SCAR TISSUE, ABSCESS, FOREIGN BODY REACTION AND REVISION SURGERY ON (B)(6) 2023. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Fistula; Obstruction/Occlusion; Unspecified Infection
MAUDE report 20472705 ↗InjurySep 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED BOWEL OBSTRUCTION, SMALL BOWEL REPAIR, PAIN, NAUSEA, ABSCESS, ENTEROTOMY, WOUND DEHISCENCE, ADHESIONS, LYSIS OF ADHESIONS, WOUND DEBRIDEMENT, WOUND VAC, MULTIPLE REVISION SURGERIES ON (B)(6) 2023. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Adhesion(s); Obstruction/Occlusion; Unspecified Infection
MAUDE report 20233462 ↗InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED MULTIPLE RECURRENT HERNIA, ADHESIONS, FOLDED MESH, INCARCERATED, ADHESIOLYSIS, REVISION SURGERY ON (B)(6) 2018, WITH NON-ATRIUM MESH IMPLANTED. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Adhesion(s); Hernia
MAUDE report 19702707 ↗InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED HERNIA RECURRENCE, INCARCERATED WITH A WITH A LOOP OF SMALL BOWEL, ADHESIONS, LYSIS OF ADHESIONS, INFLAMMATION, INCORPORATED MESH, NAUSEA AND VOMITING, REVISION SURGERY ON (B)(6) 2012 WITH NON ATRIUM MESH IMPLANTED, ADDITIONAL SURGERY, PAIN, AND ABDOMINAL WALL RECONSTRUCTION. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Adhesion(s); Hernia; Pain
MAUDE report 19702670 ↗InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED REVISION SURGERY ON (B)(6) 2023 FOR INCARCERATED HERNIA RECURRENCE, ADHESIONS, LYSIS OF ADHESIONS. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Adhesion(s); Hernia
MAUDE report 19701006 ↗InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED REVISION SURGERY ON (B)(6) 2014 FOR A RECURRENT LEFT INGUINAL HERNIA, LEFT VARICOCELE LIGATION AND LEFT EPIDIDYMECTOMY, CORD LIPOMA. NOTE: RIGHT SIDE IMPLANT AND REPAIR HAD NO ADVERSE EFFECTS. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Hernia
MAUDE report 19700964 ↗
Other Atrium Medical Corporation products
- ADVANTA SLIDER GDS51 models · 76 reports · 51 recalls
- FLIXENE SLIDER GDS17 models · 52 reports · 17 recalls
- PROLITE23 models · 515 reports
- OASIS6 models · 270 reports · 4 recalls
- PROLOOP12 models · 355 reports
- EXPRESS3 models · 142 reports · 4 recalls
- OCEAN10 models · 111 reports · 4 recalls
- iCAST29 models · 197 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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