Parietex TECT1612ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521180239), received between Dec 14, 2017 and Jul 12, 2024 — classified as 12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 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, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19731102 ↗
• InjuryFeb 6, 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, INCARCERATED SIGMOID COLON, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Pain; Swelling/ Edema; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 18654882 ↗
• InjuryMar 31, 2023Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Integrity 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MESH CONTRACTION, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, MESH REMOVAL, EXPLORATORY SURGERY, MEDICATION.

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

  MAUDE report 16660582 ↗
• InjuryMar 10, 2022Mechanics 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 RECURRENCE, PAIN, VERY HARDENED TISSUE, MENTAL PAIN/ANGUISH, SCARRING, DISFIGUREMENT, DEFECTIVE MESH, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS, AND FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Emotional Changes; Hernia; Nerve Damage; Neuralgia; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 13720640 ↗
• InjuryMar 8, 2021Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, UNINCORPORATED MESH, PURULENT MATERIAL, INFLAMMATION, LEFT INGUINAL WOUND, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE OF GROIN, REMOVAL OF MESH, INTERVENTION SURGERY.

  Patient problems: Abdominal Distention; Abscess; Distress; Impaired Healing; Inflammation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11435070 ↗
• InjuryFeb 1, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, ADHESIONS, SCARRING, NERVE DAMAGE, MESHOMA, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Discomfort; Failure of Implant; Hernia; Nerve Damage; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11258877 ↗
• InjuryJan 28, 2020Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF RECURRENT BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH MIGRATE, MESH NON-INCORPORATED, AND PAIN. CONCOMITANT DEVICE: ETHICON SECURESTRAP 5 MM ABSORBABLE STRAP (STRAP25, LOT#GJ6387)

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

  MAUDE report 9639094 ↗
• InjuryJan 28, 2020Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL IMPLANT.

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

  MAUDE report 9639077 ↗
• InjuryJan 28, 2020Material 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fluid Discharge; Hematoma; Hernia; Injury; Nodule; Pain; Unspecified Tissue Injury

  MAUDE report 9639046 ↗
• InjuryJul 3, 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 THERAPEUTIC TREATMENT. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 8761538 ↗
• InjuryMay 1, 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 THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, AND BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS.

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

  MAUDE report 8570163 ↗
• InjuryDec 14, 2017Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT LAPAROSCOPIC TOTAL EXTRAPERITONEAL RIGHT INGUINAL HERNIA REPAIR WITH MESH, LAPAROSCOPIC TOTAL EXTRAPERITONEAL LEFT INGUINAL HERNIA REPAIR WITH MESH, LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH AND LAPAROSCOPIC CLOSURE OF BLADDER LACERATION. THE PATIENT HAD REVISION SURGERY 2 MONTHS POST SURGERY. THE PATIENT EXPERIENCED CHRONIC PAIN, RECURRENCE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aspiration/Inhalation; Chest Pain; Fibrosis; Foreign Body In Patient; Hernia; Injury; No Code Available; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting

  MAUDE report 7117185 ↗