Parietex PCO2H1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521178458), received between Nov 22, 2017 and Oct 15, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 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 HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ADHESIONS, RECURRENCE, ONGOING REFLUX, NAUSEA, VOMITING, POSTPRANDIAL EPIGASTRIC PAIN, PAIN, SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC REDO PARAOESOPHAGEAL HERNIA REPAIR WITH FUNDOPLICATION; GASTROPEXY, FLEXIBLE EDG, MESH REVISION.

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

  MAUDE report 23303506 ↗
• InjurySep 6, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL PAIN, ADHESIONS, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, AND LYSIS OF ADHESIONS.

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

  MAUDE report 12431059 ↗
• InjuryDec 29, 2020Adverse 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 FOREIGN BODY GIANT CELL REACTION AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Diarrhea; Dysphagia/ Odynophagia; Erosion; Fever; Foreign Body Reaction; Inflammation; Nausea; Pain; Perforation; Sepsis; Tachycardia; Unspecified Tissue Injury; Vomiting; Weight Changes

  MAUDE report 11089496 ↗
• InjurySep 24, 2020Adverse 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 HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, LUNG WAS ADHESED TO HERNIA SAC, PAIN, CHRONIC NAUSEA, FIBROSIS, SCAR TISSUE, RETCHING ATTACKS, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LEFT THORACOTOMY, HERNIA REPAIR WITH NEW MESH, BELSEY IV FUNDOPLICATION AND EGD, MEDICATION.

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

  MAUDE report 10584066 ↗
• InjuryNov 22, 2017Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; 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 LAPAROSCOPIC REDUCTION OF HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS, MESH ERODED INTO ESOPHAGUS AND STOMACH, NAUSEA, VOMITING, DIARRHEA, MESH MIGRATION, UPPER GI BLEEDING, INFLAMED MEMBRANOUS FIBROADIPOSE CONNECTIVE TISSUE WITH FOCAL SQUAMOUS EPITHELIAL LINING AND ¿SULFUR GRANULES¿ CONSISTENT WITH ACTINOMYCES ORGANISMS, INFECTION, ABSCESS, AND DYSPHAGIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REPAIR OF HIATAL HERNIA, EXPLANT OF ERODED MESH, DOR FUNDOPLICATION, GASTROSTOMY TUBE, UPPER FLEXIBLE ENDOSCOPY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blood Loss; Diarrhea; Dysphagia/ Odynophagia; Erosion; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Nausea; No Code Available; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 7053116 ↗