Parietex PCO9XRecalls & reported problems

Summary

The FDA's MAUDE database contains 446 adverse event reports that list this exact device (DI 10884521179875), received between Aug 25, 2017 and Sep 25, 2026 — classified as 1 death, 445 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (124 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 446 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50903382 ↗
• InjuryJun 11, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25473329 ↗
• InjuryMay 8, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 25124822 ↗
• InjuryMar 10, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24563101 ↗
• InjuryMar 10, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE, NUMBNESS, BLOATING. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT-SCAN, REVISION SURGERY, MESH REVISION, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 24562397 ↗
• 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 THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, IRRITATION, MESH PULLED AWAY, MESH DETACHMENT, GRANULOMA, PAIN, & DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL MESH REMOVAL & MESH REMOVAL.

  Patient problems: Discomfort; Granuloma; Hernia; Pain; Skin Inflammation/ Irritation; Unspecified Tissue Injury

  MAUDE report 23408269 ↗
• InjurySep 11, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, DISABILITY, EMOTIONAL CHANGES, HERNIA, ABDOMINAL PAIN, BOWEL ISSUES.

  Patient problems: Abdominal Pain; Emotional Changes; Hernia; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 23027629 ↗
• InjuryJun 30, 2025Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH FAILURE, MESH DISPLACEMENT, FOREIGN BODY GIANT CELL REACTION, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND EMERGENCY ROOM TREATMENT.

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

  MAUDE report 22367037 ↗
• InjuryMay 5, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21962769 ↗
• InjuryMay 2, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21953208 ↗
• InjuryMar 31, 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 INFECTION, ADHESIONS, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION.

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

  MAUDE report 21734788 ↗
• InjuryMar 24, 2025Material 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, PAIN, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, NAUSEA, EMESIS, ABDOMINAL CRAMPS, INFECTION, AND BLEEDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, AND BOWEL RESECTION.

  Patient problems: Abdominal Cramps; Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Nausea; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 21680107 ↗
• InjuryFeb 5, 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, RECURRENCE, INFLAMMATION, ALLERGIC REACTION, ADHESIONS, FIBROSIS.

  Patient problems: Adhesion(s); Fibrosis; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 21315599 ↗
• InjuryNov 25, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INCARCERATED HERNIA RECURRENCE, CHRONIC BOWEL OBSTRUCTION, ADHESIONS, (&) MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, ENTEROLYSIS, ENDOSCOPIC BILATERAL ABDOMINAL COMPONENT SEPARATION, (&) MESH REVISION.

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

  MAUDE report 20775496 ↗
• InjuryOct 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, BULGING. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR.

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

  MAUDE report 20432405 ↗
• InjurySep 20, 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 ENLARGED TESTICLES, ABNORMAL BOWEL MOVEMENTS, PAIN, RECURRENCE, HEMATOMA, INFLAMMATION, ADHESIONS, BLEEDING, SEVERED NERVES ON LEFT SIDE OF STOMACH, AND STOMACH BULGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nerve Damage; Pain; Swelling/ Edema; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 20269329 ↗
• 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 20077570 ↗
• 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 HERNIA, INFECTION, ADHESIONS, PAIN, SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND SMALL BOWEL RESECTION.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Emotional Changes; Hernia; Impaired Healing; Inflammation; Nausea; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 19968653 ↗
• InjuryJul 23, 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.

  Patient problems: Adhesion(s); Burning Sensation; Cramp(s) /Muscle Spasm(s); Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19812598 ↗
• InjuryJul 23, 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.

  Patient problems: Adhesion(s); Burning Sensation; Cramp(s) /Muscle Spasm(s); Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19812595 ↗
• InjuryJul 23, 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19811390 ↗
• InjuryJul 11, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, BULGING ABDOMEN, MESH MIGRATION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19726163 ↗
• InjuryMay 10, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, & PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES.

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

  MAUDE report 19292084 ↗
• InjuryMay 10, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, ADHESIONS, PAIN, SEROMA, INFLAMMATION, ORGAN PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, WOUND VAC PLACEMENT, REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Heartburn/Indigestion; Hernia; Inflammation; Internal Organ Perforation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19291005 ↗
• InjuryMar 26, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY.

  Patient problems: Hernia; Nausea; Pain; Unspecified Tissue Injury

  MAUDE report 18980452 ↗