Parietex PCO2520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 10884521179837), received between Aug 7, 2017 and Apr 15, 2026 — classified as 5 deaths, 234 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (73 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 239 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24887123 ↗
• InjuryDec 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, SEROSAL TEARS, SCARRING, WEIGHT LOSS, LIMITED MOBILITY, DISCOMFORT, BOWEL ISSUES. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REPAIRED AND MEDICATION.

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

  MAUDE report 23687070 ↗
• InjuryNov 3, 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 23458237 ↗
• InjuryOct 28, 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 23405879 ↗
• InjuryOct 15, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, MESH FAILURE, PAIN, ADHESIONS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION.

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

  MAUDE report 23304210 ↗
• InjuryAug 22, 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Anxiety; Constipation; Depression; Distress; Fistula; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22877898 ↗
• DeathAug 22, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Integrity Problem; 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, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Distress; Hernia; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 22874360 ↗
• InjuryAug 4, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, OBSTRUCTION, INFECTION, INFLAMMATION, BLOATING, MUSCULAR ACUTE PAIN, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, AND EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS.

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

  MAUDE report 22707794 ↗
• InjuryFeb 14, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 AND INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CRAMPING, DISCOMFORT, TIGHTNESS IN STOMACH AND GROIN, DIFFICULTY WITH BOWEL MOVEMENTS, LACK OF INCORPORATION, RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH AND REMOVAL OF OLD MESH.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Hernia; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 21385654 ↗
• InjuryFeb 12, 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, ADHESIONS, MESH MIGRATION, PAIN, & PAINFUL BOWEL MOVEMENTS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 21368359 ↗
• 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 RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19955452 ↗
• InjuryJul 31, 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.

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

  MAUDE report 19874850 ↗
• InjuryJun 14, 2024Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, MESH NOT INCORPORATED, RECURRENCE, INFECTION, PAIN, PUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19541037 ↗
• InjuryFeb 14, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SHIFTING INTESTINE, HIGHLY IRRITABLE, PROTRUDING SMALL BOWEL, RECURRENCE, OPEN DRAINING WOUND, LOSS OF APPETITE, AND SEVERE AND CHRONIC PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, PARTIAL EXPLANT SURGERY, AND SURGERY TO REMOVE MESH.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Discomfort; Fluid Discharge; Hernia; Impaired Healing; Irritability; Pain; Unspecified Tissue Injury

  MAUDE report 18705710 ↗
• InjuryDec 27, 2023Degraded; Degraded

  ACCORDING TO THE REPORTER, POST-OPERATIVE A PROMONTOFIXATION BY LAPAROSCOPY WITH SUSPENSION OF THE CERVIX, THE SURGEON FOUND THAT THE MESH IS STILL WELL FIXED BUT IT IS DISTENDED AS IF IT HAD LOST IT'S ELASTICITY. THE SURGEON REPLACED THE MESH AND USES A HEAVIER MESH.

  Patient problems: Prolapse; Tissue Breakdown

  MAUDE report 18406410 ↗
• InjuryOct 13, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND MEDICATION.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 17936169 ↗
• InjurySep 29, 2023Material 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH EVENTRATION, PAIN, RECURRENCE, ADHESIONS, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL MESH EXPLANT, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

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

  MAUDE report 17843715 ↗
• InjurySep 18, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, 106 DAYS POSTOPERATIVE TO PROMONTOFIXATION BY LAPAROSCOPY WITH SUSPENSION OF THE UTERINE CERVIX USING MESH, ON RE-INTERVENTION, IT WAS FOUND THAT THE PROSTHESES WERE STILL WELL FIXED BUT HAD FINALLY DISTENDED AS IF THEY HAD LOST THE ELASTICITY OR LOSS OF RETURN FORCE AFTER DISTENSION. THE SURGEON ATTRIBUTED THIS TO THE INSUFFICIENT WEIGHT OF THE PROSTHESIS, WHICH LED HIM TO WANT USE HEAVIER PROSTHESES IN THE EVENT OF A RECURRENCE WITHOUT THE PROTHESES COMING LOOSE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED A COMPETITOR DEVICE.

  Patient problems: Tissue Breakdown

  MAUDE report 17767965 ↗
• InjuryAug 15, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, THE MATERIAL WAS ALREADY DISTENDED AS IF DEVICE LOST ELASTIC PROPERTY (LOSS OF RECALL FORCE AFTER DISTENTION).

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 17553427 ↗
• InjuryAug 15, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO PROMONTOFIXATION BY LAPAROSCOPIC EXAMINATION WITH A SUSPENSION OF THE CERVIX USING MESH, THE MATERIAL WAS ALREADY DISTENDED AS IF DEVICE LOST ELASTIC PROPERTY (LOSS OF RECALL FORCE AFTER DISTENTION). A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 17551943 ↗
• InjuryAug 14, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, SIXTEEN MONTHS POST-OPERATIVE TO PROMONTOFIXATION BY LAPAROSCOPIC EXAMINATION WITH A SUSPENSION OF THE CERVIX USING MESH, REOPERATION WAS PERFORMED AND FOUND THAT ALTHOUGH THE MESH WAS STILL SECURED, THE MATERIAL WAS ALREADY DISTENDED AS IF DEVICE LOST ELASTIC PROPERTY (LOSS OF RECALL FORCE AFTER DISTENTION). THE MESH WAS REPLACED WITH A COMPETITOR DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 17546719 ↗
• InjuryAug 3, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 RECURRENCE, ADHESIONS, PAIN, MESH EROSION, AND LOSS OF DOMAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17454840 ↗
• InjuryJun 28, 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, SMALL BOWEL OBSTRUCTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND ADDITIONAL MESH IMPLANTED.

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

  MAUDE report 17219521 ↗
• InjuryJun 13, 2023Migration 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 RECURRENCE, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 17122142 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 PAIN, RECURRENCE, INFECTION, HEMATOMA, ADHESIONS, OBSTRUCTIONS, SEROMA,PERFORATION, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 17088465 ↗