Parietex PCO2520FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521179813), received between Dec 12, 2017 and Oct 10, 2024 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED THICKENED MID SMALL BOWEL LOOPS, SMALL BOWEL OBSTRUCTION, INFLAMMATION, FREE FLUID, WEAKNESS IN ABDOMINAL WALL, ABDOMINAL PAIN, CONSTIPATION, ACUTE ABDOMEN, OBSTRUCTED HERNIA ENTANGLED IN MESH, INFECTED MESH, VOMITING, <(>&<)> WOUND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, MULTIPLE HOSPITALIZATIONS, INCISIONAL HERNIA REPAIR WITH MESH, MESH REVISION, MESH REMOVAL, LAPAROTOMY HERNIA REPAIR, IV FLUIDS, PAIN MEDICATION, <(>&<)> NG TUBE.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Constipation; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 20424247 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DIFFUSE DEFICIENCY OF LOWER ABDOMINAL WALL, & DISCOMFORT.

  Patient problems: Discomfort; Muscle Weakness/Atrophy; Unspecified Tissue Injury

  MAUDE report 20396488 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ABDOMINAL BULGE, DIVARICATION OF RECTUS SHEATH, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MRI. CONCOMITANT DEVICE: UNKNOWN PROTACKS.

  Patient problems: Abdominal Distention; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 20371072 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, & INFLAMMATORY STRANDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN.

  Patient problems: Hernia; Inflammation; Unspecified Tissue Injury

  MAUDE report 20258235 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF LUMBAR HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BULGE, HERNIA RECURRENCE, ADHESIONS, PAIN, ERYTHEMA, WOUND OOZING BLOOD & YELLOW FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, & IV ANTIBIOTICS.

  Patient problems: Abdominal Distention; Adhesion(s); Erythema; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Pain; Purulent Discharge; Unspecified Tissue Injury

  MAUDE report 20190493 ↗
• InjuryJan 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THERE WERE NO PROBLEMS DURING THE SURGERY IN 2014. THIS TIME, THE PATIENT WAS EXAMINED FOR A RECURRENCE OF VENTRAL HERNIA, AND THE X-RAYS SHOWED THAT THE HERNIA HAD BEEN FORMED FROM THE CENTER OF THE MESH, HOWEVER, DURING A REPEAT SURGERY, THE CENTER OF THE MESH WAS FOUND TO HAVE BEEN DAMAGED AND IT WAS FOUND THAT THE HERNIA WAS STARTING FROM THAT HOLE. A MESH PLACEMENT WITH INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) PLUS.

  Patient problems: Hernia; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 18456276 ↗
• InjuryOct 1, 2022Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS, INFLAMMATION, INFECTION, BOWEL PROBLEMS, SUFFERING, MENTAL ANGUISH, MENTAL PAIN, EMOTIONAL DISTRESS, DISCOMFORT, DEFECTIVE DEVICE, MESH FAILURE, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15525626 ↗
• InjuryMay 3, 2022Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, PAIN, OBSTRUCTION, SEROMA, INFLAMMATION, SCARIFICATION, MESH ENCAPSULATION, INADEQUATE INGROWTH, AND MESH DEFORMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION AND REVISION SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cellulitis; Discomfort; Erythema; Fever; Fluid Discharge; Foreign Body Reaction; Impaired Healing; Inflammation; Nausea; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 14269484 ↗
• InjuryApr 7, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, BOWEL COMPLICATIONS, LOSS OF ENJOYMENT OF LIFE, DISABILITY, LOSS OF MENTAL HEALTH, SCARRING, DISFIGUREMENT, DEFECTIVE MESH, MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 14049022 ↗
• InjuryJul 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST OPERATIVELY, A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE WAS DONE EIGHT YEARS AGO, THEN THE PATIENT FELT A TEARING SENSATION LAST YEAR. A MONTH AGO, THE PATIENT HAD TO UNDERGO A COLOSCOPY VIDEO BECAUSE THERE WAS AN OCCLUSION DUE TO THE HERNIA RECURRENCE DUE TO A LARGE MESH TEARING. THE MESH WAS BROKEN IN ITS MIDDLE AND NOT AT THE EXTREMITIES. THE PATIENT HAD TO UNDERGO ANOTHER LAPAROSCOPIC VENTRAL HERNIA SURGERY WITH A NEW MESH AND THE DEFECT WAS CLOSED BY A TROCAR SITE CLOSURE PRODUCT, TWO SUTURES AND MORE OR LESS 25 TACKS OF A DIFFERENT MANUFACTURER TO RESOLVE THE ISSUE. THE PATIENT WAS HOSPITALIZED.

  Patient problems: Hernia; Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 12221032 ↗
• MalfunctionMar 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON A ROBOTIC LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) REDO PROCEDURE, IT WAS FOUND THAT THE MESH IMPLANTED BACK IN (B)(6) 2017 RUPTURED IN THE MIDDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547925 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RECURRENT VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, PSYCHOLOGICAL STRESS, DEPRESSION, AND SEVERE/ PERMANENT INJURY. CONCOMITANT DEVICE: VENTRALEX 002011552 ST MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Distress; Emotional Changes; Injury; Pain; Unspecified Tissue Injury

  MAUDE report 9544747 ↗
• InjuryMay 25, 2019Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RECURRENT VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, ADHESIONS, PANNUS AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Corneal Pannus; Failure of Implant; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8642981 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT ABDOMINAL WALL INFECTION, FLUID WAS VISUALIZED RADIOGRAPHICALLY AROUND THE MESH MATERIAL, RECURRENCE, SUSPECTED INFECTED MESH MATERIAL, ADHESIONS, ABDOMINAL CELLULITIS, PURULENT DRAINAGE, ABDOMINAL OBESITY, PAIN, AND ABDOMINAL PAIN SYNDROME. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, A DHESIOLYSIS, EXCISION OF OLD MESH, ANTIBIOTICS, COMPLEX REOPERATIVE REPAIR OF VENTRAL INCISIONAL HERNIA WITH BIOLOGICAL XENOGRAFT, ABDOMINAL WALL CLOSURE REINFORCEMENT, AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Anxiety; Ascites; Cellulitis; Depression; Emotional Changes; Fluid Discharge; Hernia; Injury; No Code Available; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Weight Changes

  MAUDE report 7107727 ↗