Parietex PCO12XRecalls & reported problems

Summary

The FDA's MAUDE database contains 446 adverse event reports that list this exact device (DI 10884521179745), received between Jun 16, 2017 and Sep 4, 2026 — classified as 3 deaths, 441 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (135 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 446 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50618947 ↗
• InjuryApr 20, 2026Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISTRESS, MESH MIGRATION, PAIN, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, INFLAMMATION, SCARRING, DEPRESSION, EMOTIONAL CHANGES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION.

  Patient problems: Adhesion(s); Depression; Distress; Emotional Changes; Hernia; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 24932385 ↗
• MalfunctionMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A PROCEDURE PERFORMED IN (B)(6) 2023 FOR A RECURRENCE OF A SUPRAUMBILICAL HERNIA INITIALLY OPERATED ON IN CHILDHOOD, THE PATIENT HAD PAIN IN THE ABDOMEN FOR THREE YEARS. THE PATIENT DEVELOPED AN IRRITABLE BOWEL SYNDROME. THE PATIENT ALSO HAS A FEELING OF HAVING AIR IN THE BELLY ALL THE TIME.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Flatus

  MAUDE report 24725308 ↗
• InjuryMar 2, 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 AN INTRAPERITONEAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24484449 ↗
• 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, recurrence, abscess, adhesions, pain, suffering. Post-operative patient treatment included revision surgery and hernia repair with new mesh.

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

  MAUDE report 23454132 ↗
• InjuryMar 3, 2025Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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, MESH FAILURE, MESH EVENTRATION, INCARCERATION OF HERNIA, ABDOMINAL PAIN, AND CONSTIPATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Constipation; Hernia; Unspecified Tissue Injury

  MAUDE report 21506474 ↗
• InjuryFeb 10, 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 PARAESOPHAGEAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, EROSION, OBSTRUCTION, PAIN, INFECTION, SEROMA, ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, STENTS PLACED, PARTIAL STOMACH REMOVAL, LYSIS OF ADHESIONS, GASTROTOMY.

  Patient problems: Abscess; Adhesion(s); Erosion; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21345754 ↗
• InjuryDec 9, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, 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 20883648 ↗
• InjurySep 30, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, RECURRENCE, ADHESIONS, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADHESIOLYSIS, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

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

  MAUDE report 20334921 ↗
• InjuryJul 31, 2024Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 MESH MIGRATION, LACK OF ADEQUATE INGROWTH, MESH DEFORMATION, RECURRENCE, INFECTION, ADHESIONS, PAIN, INFLAMMATION, SCARRING, MESH ENCAPSULATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19874718 ↗
• InjuryJul 15, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, MESH MIGRATION, ABDOMINAL PAIN, AND CONSTIPATION.

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

  MAUDE report 19743299 ↗
• InjuryJul 15, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, MESH MIGRATION, ABDOMINAL PAIN, AND CONSTIPATION.

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

  MAUDE report 19743219 ↗
• InjuryJul 11, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, PAIN, INFECTION, ADHESIONS, EMOTIONAL CHANGES, ABSCESS, DISCOMFORT, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, MEDICATION, EXPLORATORY SURGERY WITH ADHESIOLYSIS, BOWEL RESECTION.

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

  MAUDE report 19722352 ↗
• InjuryJul 9, 2024Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION.

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

  MAUDE report 19705958 ↗
• InjuryJun 13, 2024Material 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, PAIN, RECURRENCE, ADHESIONS, HERNIA PUSHING NAVEL OUT. POST-OPERATIVE PATIENT TREATMENT INCLUDED CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAM, REPAIR OF HERNIA.

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

  MAUDE report 19530127 ↗
• InjuryMay 14, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Integrity Problem; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, 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 19311163 ↗
• InjuryApr 26, 2024Adverse 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 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; Nausea; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19194353 ↗
• InjuryApr 26, 2024Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19194345 ↗
• InjuryApr 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, OBSTRUCTION, RECURRENT BULGE, NAUSEA, NOT PASSING GAS OR STOOL, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Hernia; Nausea; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19046921 ↗
• InjuryMar 7, 2024Migration 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 RECURRENCE, INFECTION, ABSCESS, ADHESIONS, SMALL BOWEL OBSTRUCTION, PAIN, SEROMA, HEMATOMA, MESH EROSION, MESH MIGRATION, SCARRING, DISFIGUREMENT, BULGING, DISTENTION URINARY URGENCY, DIARRHEA, NAUSEA, VOMITING, CRAMPING, DISCOMFORT, TENDERNESS, INCARCERATION, SEROSAL TEAR, SEPSIS, MENTAL ANGUISH, AND ANXIETY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND SMALL BOWEL RESECTION.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Diarrhea; Discomfort; Emotional Changes; Erosion; Hematoma; Hernia; Inflammation; Micturition Urgency; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 18862815 ↗
• InjuryDec 12, 2023Adverse 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, OBSTRUCTION, PAIN, HEMATOMA, INFLAMMATION. TREATMENT INCLUDED MEDICATION, PARTIAL REVISION, HERNIA REPAIR WITH NEW MESH, REVISION OF THE MESH FIVE YEARS AFTER IMPLANT. DURING THE REVISION, SCAR TISSUE WAS NOTED.

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

  MAUDE report 18312668 ↗
• InjuryNov 17, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Bruise/Contusion; Discomfort; Emotional Changes; Hernia; Inflammation; Itching Sensation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18161620 ↗
• InjuryNov 17, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Bruise/Contusion; Discomfort; Emotional Changes; Hernia; Inflammation; Itching Sensation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18161562 ↗
• InjurySep 14, 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, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 17751401 ↗
• InjuryAug 16, 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.

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

  MAUDE report 17561533 ↗