Parietex PCO2015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 364 adverse event reports that list this exact device (DI 10884521179769), received between Sep 19, 2017 and Jul 30, 2026 — classified as 1 death, 361 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (103 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 25 most recent of 364 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  The patient's attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced mesh failure, recurrence, pain, adhesions, and obstruction. Post-operative patient treatment included removal of mesh, and hernia repair.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 50089738 ↗
• InjuryJul 27, 2026Adverse 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 the implant, the patient experienced pain, hernia recurrence, adhesions, obstructions, & GI issues. Post-operative patient treatment included exploratory laparotomy, lysis of adhesions, component release, & hernia repair with mesh.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 50048114 ↗
• InjuryDec 2, 2025Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23697186 ↗
• InjurySep 15, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 EMOTIONAL DISTRESS, BLEEDING, HEMATOMA, HEMORRGRAPHIC SHOCK, MESH MIGRATION, ABSCESS, PAIN, RECURRENCE, INFECTION, NERVE DAMAGE, PERFORATION, IMPAIRED HEALING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL MESH REMOVAL, WOUND EXPLORATION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Nerve Damage; Pain; Perforation; Shock; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23055948 ↗
• InjuryJul 29, 2025Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, RECURRENCE AND OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 22648235 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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 EMOTIONAL DISTRESS, HERNIA RECURRENCE, INFECTED MESH, ABSCESS, FISTULA, PAIN, SUFFERING, SEROMA, PUS POCKET, SEPSIS, CHRONIC DRAINING SINUS, FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, MESH REMOVAL, HERNIA REPAIR, INCISION DRAINAGE, DRAINAGE OF PUS POCKET, EXCISION OF FISTULA, IV ORAL ANTIBIOTICS, WOUND CARE, DIAGNOSTIC LAPAROSCOPY, OPEN REPAIR OF HERNIA WITH SUTURES.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Fistula; Fluid Discharge; Hernia; Pain; Purulent Discharge; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21866930 ↗
• InjuryMar 31, 2025Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, PAIN, RECURRENCE, ADHESIONS, LOSS OF APPETITE, SWELLING, SHORTNESS OF BREATH, LEFT SIDED CHEST PAIN, NAUSEA, VOMITING, ABDOMINAL PAIN, <(>&<)> TENDERNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Chest Pain; Decreased Appetite; Discomfort; Dyspnea; Hernia; Nausea; Pain; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 21735257 ↗
• InjuryDec 10, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, SEROMA, DISCOMFORT, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MULTIPLE SURGERIES, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 20895443 ↗
• InjuryAug 27, 2024Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, RECURRENCE, ADHESIONS, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION.

  Patient problems: Adhesion(s); Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 20077543 ↗
• InjuryAug 21, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 20020130 ↗
• InjuryAug 12, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, OBSTRUCTION, PAIN, SEPSIS, SEVERE ADHESIVE DISEASE, INCARCERATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PLACEMENT OF WOUND VAC.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Discomfort; Hernia; Inflammation; Obstruction/Occlusion; Pain; Sepsis; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19968283 ↗
• InjuryAug 9, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA, PAIN, HERNIA, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Nausea; Pain; Unspecified Tissue Injury

  MAUDE report 19955162 ↗
• InjuryJun 17, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH HERNIATED INTO DEFECT, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 19554098 ↗
• InjuryJun 11, 2024Mechanics 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED FLUID COLLECTION, PAIN, NAUSEA, EMESIS, DRAINAGE FROM BELLY BUTTON, FATIGUE, DIAPHORESIS, FAILURE, RECURRENCE, ADHESIONS, EMOTIONAL CHANGES, DISCOMFORT < (>&<)> CHILLS. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, PAIN MEDICATION, < (>&<)> IV FLUIDS. CONCOMITANT DEVICE: UNKNOWN PROTACK.

  Patient problems: Adhesion(s); Ascites; Chills; Diaphoresis; Discomfort; Emotional Changes; Fatigue; Fluid Discharge; Hernia; Nausea; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 19514932 ↗
• InjuryJun 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 THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, LOSS OF TISSUE, ADHESIONS, OBSTRUCTIONS, INTESTINAL TEAR, SHORTNESS OF BREATH, SEVERE WEIGHT LOSS (FROM 185 LBS TO 127 LBS), ANXIETY, DEPRESSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, ABDOMINAL BINDING, ADHESIOLYSIS, BOWEL RESECTION.

  Patient problems: Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Dyspnea; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 19463739 ↗
• InjuryMay 22, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Kidney Infection; Pain; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 19378204 ↗
• InjuryApr 30, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, ADHESIONS, ABSCESS, AND ABDOMINAL WALL DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED DISSECTION, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abscess; Adhesion(s); Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19215574 ↗
• InjuryMar 29, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE, DISTENTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 19005110 ↗
• InjuryMar 21, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL MUSCLE CRAMPING, DIGESTIVE TRACT ISSUES, CONTINUOUS GAS, AND BLOATING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Distention; Cramp(s) /Muscle Spasm(s); Flatus; Unspecified Tissue Injury

  MAUDE report 18955056 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn

  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 HOLES/RIPS IN MESH, RECURRENCE, INFECTION, ADHESIONS, OBSTRUCTION, MESH EROSION, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, REVISION SURGERY AND SMALL BOWEL RESECTION.

  Patient problems: Adhesion(s); Discomfort; Erosion; Hernia; Inflammation; Nodule; Obstruction/Occlusion; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18877140 ↗
• InjuryFeb 27, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, MESH INCORPORATED INTO ABDOMINAL WALL, PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, ANXIETY, DISCOMFORT, DISABILITY, OVARIAN MASS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Anxiety; Discomfort; Hernia; Inflammation; Nodule; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 18793384 ↗
• InjuryDec 12, 2023Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION SURGERY.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18315352 ↗
• InjuryNov 17, 2023Adverse 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 A HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, FISTULA, INFECTION, BLOATING, RECURRENCE, ABDOMINAL PAIN, OBSTRUCTION, GAS, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY LAPAROTOMY, LYSIS OF ADHESIONS, EXCISION AND REMOVAL OF MESH, AND BOWEL RESECTION, MEDICATION, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Fistula; Flatus; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18160816 ↗
• InjuryOct 31, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, PAIN, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL, AND REVISION OF MESH.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18043695 ↗
• InjuryOct 24, 2023Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE AND EXTENSIVE ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 17999017 ↗