Parietex PCO2H4Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521178472), received between Jul 18, 2018 and Jun 17, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Degraded; Degraded

  ACCORDING TO THE REPORTER, IN (B)(6) 2023 A LAPAROSCOPIC ESOPHAGEAL HIATAL HERNIA WAS PERFORMED. THE MESH WAS PLACED AFTER HERNIA ORIFICE CLOSURE AND HAD NO ISSUE. TWO YEARS LATER, THE PATIENT HAD RECURRENCE ACCOMPANIED BY GASTRIC MESH EROSION, STOMACH PERFORATION, ABSCESS FORMATION AND RIGHT-SIDE HEART FAILURE. IT WAS NOTED THAT A SECOND SURGERY IS SCHEDULED.

  Patient problems: Abscess; Heart Failure/Congestive Heart Failure; Hernia; Perforation

  MAUDE report 22248093 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF AN ESOPHAGEAL HIATAL HERNIA, FIXATION WAS PERFORMED USING THE MESH. THE FOLLOWING DAY, THE PATIENT REPORTED ACUTE ABDOMINAL PAIN (EPIGASTRIC PAIN). AFTER A CT SCAN, AN EMERGENCY LAPAROTOMY WAS PERFORMED, DURING WHICH THE MESH WAS COMPLETELY REMOVED. AFTER THE MESH REMOVAL, AN INTRA-ABDOMINAL OBSERVATION REVEALED THAT THE SYMPTOMS WERE NOT CAUSED BY THE MESH. HOWEVER, THE CAUSE OF THE PAIN REMAINS UNDETERMINED. THE INCISION RANGE HAD EXCEEDED 1 INCH, THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES, AND SINCE THE PROCEDURE TURNED INTO AN OPEN MESH REMOVAL, THE HOSPITALIZATION PERIOD WAS EXPECTED TO BE EXTENDED BY ONE TO TWO WEEKS.

  Patient problems: Abdominal Pain; Laceration(s)

  MAUDE report 20241096 ↗
• InjuryJul 18, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOUR YEARS AFTER A NISSEN FUNDOPLICATION ON HIATAL HERNIA, THE PATIENT RETURNED AT THE HOSPITAL THROWING UP AND WITH PAIN. THE PATIENT'S ESOPHAGUS WAS PERFORATED WHICH REQUIRED AN EXPLORATORY LAPAROTOMY, INTESTINAL RESECTION, AND REMOVAL OF THE MESH. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM, AN EXTENDED INCISION BY MORE THAN 1 INCH OR 2.54CM AND TISSUE DAMAGE. THE EVENT ALSO LEAD TO EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: No Code Available; Pain; Perforation of Esophagus; Tissue Damage; Vomiting

  MAUDE report 7699573 ↗