Parietex PCO2015OSXRecalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10884521179806), received between Nov 15, 2017 and Oct 28, 2025 — classified as 95 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (28 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 95 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH EXTRUDING, OPEN DRAINING WOUND, FAILURE TO GRANULATE, CHRONICALLY EXPOSED MESH, PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Discomfort; Fluid Discharge; Impaired Healing; Pain; Unspecified Tissue Injury

  MAUDE report 23405805 ↗
• InjuryApr 1, 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, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21739843 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20571279 ↗
• 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, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, SMALL BOWEL RESECTION.

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

  MAUDE report 19966100 ↗
• InjuryNov 27, 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 RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL SURGERY.

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

  MAUDE report 18213731 ↗
• InjurySep 20, 2023Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity 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 RECURRENCE, ADHESIONS, AND MESH CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17785673 ↗
• InjuryAug 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 THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, FISTULA, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC, BOWEL RESECTION, AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17565617 ↗
• InjuryJul 10, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, SMALL BOWEL OBSTRUCTION, PAIN, SEROMA, SMALL BOWEL COLLAPSE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, REVISION SURGERY, MESH REMOVAL, WOUND VAC.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Nodule; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17294665 ↗
• InjuryJun 29, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BOWEL HAS TWISTED TWICE, BLOATED IN THE AREA OF THE SURGERIES, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, SEPSIS, AND GANGRENE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND MEDICATION.

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

  MAUDE report 17231962 ↗
• InjuryMar 24, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanics Altered; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, DISCOMFORT, INFLAMMATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Discomfort; Distress; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 16612165 ↗
• InjuryFeb 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS TO MESH AND COLON, NAUSEA, ABDOMINAL PAIN, DISCOMFORT, VOMITING, (&) PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

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

  MAUDE report 16436879 ↗
• InjuryFeb 7, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 16315461 ↗
• InjuryJan 5, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, REVISION SURGERY.

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

  MAUDE report 16103343 ↗
• InjuryNov 21, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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, MESH DETACHMENT, MESH TORN, RECURRENCE, INFLAMMATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, USE OF DRAIN, AND UMBILECTOMY.

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

  MAUDE report 15833893 ↗
• InjuryOct 20, 2022Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, & ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 15638559 ↗
• InjuryOct 6, 2022Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFECTION, ADHESIONS, INFLAMMATION, ABDOMINAL PAIN, ABSCESS, MESH MIGRATION, AND DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Fluid Discharge; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15552353 ↗
• InjuryJun 16, 2022Adverse 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 RECURRENCE, ADHESIONS, PAIN, ATTENUATION OF THE SIDE OF PREVIOUS REPAIR, AND FIBROTIC REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Fibrosis; Hernia; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 14717752 ↗
• InjuryFeb 4, 2022Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, SCARRING, SWELLING, CRAMPING, BULGING, DIGESTIVE COMPLICATIONS, BOWEL INVOLVEMENT, LIVER DAMAGE, MENTAL ANGUISH AND ANXIETY. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Anxiety; Cramp(s) /Muscle Spasm(s); Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Nausea; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 13459753 ↗
• InjuryJan 10, 2022Migration 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, AND MESH PULLED AWAY FROM ABDOMINAL WALL.

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

  MAUDE report 13205856 ↗
• InjuryDec 2, 2021Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, AND HEMATOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Hematoma; Hernia; Nodule; Pain; Unspecified Tissue Injury

  MAUDE report 12917543 ↗
• InjuryAug 16, 2021Degraded; Material Deformation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, ADHESIONS, RECURRENCE, PAIN AND EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Erosion; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 12324573 ↗
• InjuryJul 29, 2021Adverse 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 INCARCERATED RECURRENT VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL WALL ABSCESS, INFECTED MESH, HERNIA RECURRENCE, RARE GRAM NEGATIVE COCCI, FIBROSIS, FAT NECROSIS, CHRONIC REACTIVE CHANGES, FLUID COLLECTION WITH SOME ASSOCIATED AIR BUBBLES, NONVIABLE TISSUE, FIBRINOUS DEBRIS, PERITONEAL FLUID, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ULTRASOUND GUIDED INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS, WOUND DEBRIDEMENT, REMOVAL OF INFECTED MESH, HERNIA REPAIR WITH MESH (NON-MEDTRONIC PRODUCT), DISSECTION OF BOWEL FROM MESH THAT HAD ADHERED TO IT, CT GUIDED PERCUTANEOUS DRAINAGE OF PERITONEAL ABSCESS, ADMISSION TO HOSPITAL, ANTIBIOTICS, NONVIABLE TISSUE DEBRIDED, WOUNDS PACKED, DRAIN PLACEMENT, IRRIGATION, REMOVAL OF TACKS/SUTURES, AND REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Fibrosis; Hernia; Necrosis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12247655 ↗
• InjuryJul 29, 2021Mechanics 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 ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, ADHESIONS, PAIN, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY SURGERY, MEDICATION, HERNIA REPAIR WITH NEW MESH, ADDITIONAL SURGERY AND REVISION SURGERY.

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

  MAUDE report 12246744 ↗
• InjuryJul 15, 2021Mechanics 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DESIGN DEFECT, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND MESH REMOVAL.

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

  MAUDE report 12174255 ↗
• InjuryMay 19, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, AND INFECTION. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, HERNIA REPAIR, MEDICATION, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Emotional Changes; Fluid Discharge; Impaired Healing; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11852055 ↗