Parietex TET1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521180345), received between Sep 12, 2018 and Oct 22, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED FLUID COLLECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED BLOODSTAINED FLUID ASPIRATION UNDER LOCAL ANESTHETIC.

  Patient problems: Ascites; Unspecified Tissue Injury

  MAUDE report 20509412 ↗
• 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, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 19954082 ↗
• InjuryJan 5, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE & CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL & REVISION SURGERY.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16109776 ↗
• InjuryJan 5, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, MESH REMOVAL, AND REVISION SURGERY.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16109770 ↗
• InjuryApr 8, 2021Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADHESIOLYSIS, MEDICATION, MESH REMOVAL, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11636532 ↗
• InjuryJul 7, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loss of or Failure to Bond; 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 AN INCARCERATED UMBILICAL HERNIA WITH OBSTRUCTION. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH MIGRATION, LACK OF INCORPORATION AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 8766080 ↗
• InjuryJun 26, 2019Adverse 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 RIGHT INGUINAL HERNIA AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN.

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

  MAUDE report 8736650 ↗
• InjuryMar 27, 2019Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MESH PROTRUSION, HERNIA RECURRENCE, BOWEL COMPLICATIONS, INCONTINENCE, FATIGUE AND EMOTIONAL PROBLEMS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Emotional Changes; Fatigue; Hernia; Incontinence; Injury; No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 8458662 ↗
• InjurySep 14, 2018Adverse 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; DENSE ADHESIONS OF THE MESH TO THE ESOPHAGUS, STOMACH, AND RETROPERITONEUM; SEVERE PAIN AND DISCOMFORT IN THE AREA OF THE IMPLANT; MENTAL ANGUISH; EMOTIONAL DISTRESS. AFTER TREATMENT, THE PATIENT EXPERIENCED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Distress; Hernia; Injury; No Code Available; Pain

  MAUDE report 7878653 ↗
• InjurySep 12, 2018Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; 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 AN ABDOMINAL HERNIA. AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. TREATMENT FOR THE ISSUE INCLUDED FOUR SURGICAL REVISION PROCEDURES STARTING FOUR MONTHS AFTER INITIAL IMPLANT.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Injury; Nerve Damage; Nodule; Pain; Purulent Discharge; Scar Tissue; Scarring; Seroma; Ulcer; Ulceration; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7867567 ↗