Parietex PCO1510FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521179684), received between Apr 4, 2018 and Oct 18, 2024 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20485357 ↗
• InjurySep 4, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HETEROGENOUS FLUID COLLECTION, HEMATOMA, TENDERNESS, INFLAMMATORY REACTION, FOREIGN BODY TYPE GIANT CELLS, ABDOMINAL PAIN, WOUND DEHISCENCE, ADHESIONS, DEPRESSION, NAUSEA, GASTRITIS AND FATIGUE. POST OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPY, EXCISION OF CORNER OF INTRA-PERITONEAL MESH, CT SCAN, ULTRASOUND, MRI, MEDICATION, HOSPITAL ADMISSION, AND USE OF A TENS UNIT.

  Patient problems: Abdominal Pain; Adhesion(s); Ascites; Depression; Discomfort; Fatigue; Foreign Body Reaction; Gastritis; Hematoma; Inflammation; Nausea; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 20141324 ↗
• MalfunctionAug 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA SURGERY, NINE YEARS AFTER THE INITIAL SURGERY, A SECOND LOOK AT THE REPAIRED AREA REVEALED WHITE DISSEMINATION ON THE ABDOMINAL WALL WHERE THE MESH WAS PLACED. IT WAS NOTED THAT THE SIZES OF THE LESION WERE 10MM X 15MM. AND 10MM.

  Patient problems: Tissue Breakdown

  MAUDE report 19932149 ↗
• InjuryNov 21, 2022Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; 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 THE IMPLANT, THE PATIENT EXPERIENCED MESH BREAK DOWN, HERNIA RECURRENCE, MESH INFECTION, GASTROINTESTINAL COMPLICATIONS, MESH ADHESIONS, CHRONIC PAIN, MESH FAILURE, SCARRING, DISFIGUREMENT, DEVICE DEFECTIVE, PSYCHOLOGICAL EMOTIONAL INJURIES, SUFFERING, LOSS OF ENJOYMENT OF LIFE, PERMANENT PHYSICAL DISABILITY, LOSS OF PHYSICAL/MENTAL/EMOTIONAL HEALTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED CORRECTIVE REVISION SURGERY,MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15840736 ↗
• InjuryOct 5, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, INFLAMMATION, BOWEL PROBLEMS, INFECTIONS, DEFECTIVE DEVICE, MESH FAILURE, SUFFERING, MENTAL ANGUISH, MENTAL PAIN, EMOTIONAL DISTRESS, DISCOMFORT, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Diarrhea; Discomfort; Distress; Emotional Changes; Fever; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nausea; Necrosis; Pain; Pneumonia; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 15546428 ↗
• InjuryApr 7, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, BOWEL COMPLICATIONS, LOSS OF ENJOYMENT OF LIFE, DISABILITY, LOSS OF MENTAL HEALTH, SCARRING, DISFIGUREMENT, DEFECTIVE MESH, MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 14049017 ↗
• InjuryJun 18, 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 A ABDOMINAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, PHYSICAL PAIN, MENTAL ANGUISH, DISABILITY, PSYCHOLOGICAL STRESS, DEPRESSION, FISTULA, ABSCESS, DISCOMFORT, ADHESIONS, RECURRENCE, SCARRING, DISCHARGE, LIGHT GREEN EXUDATE, TRACT, INFLAMMATION, NEUTROPHILS, RARE GRAM + COCCI, STAPHYLOCOCCUS AUREUS, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF INFECTED MESH, SMALL BOWEL RESECTION, ANTIBIOTICS, DRAIN PLACED, LYSIS OF ADHESIONS, EXCISION OF SCAR, WOUND VAC, VAC REMOVED, AND HOSPITALIZATION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Depression; Discomfort; Distress; Emotional Changes; Fistula; Fluid Discharge; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12028513 ↗
• InjuryMay 28, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION/INFECTED MESH, ABSCESS, PAIN, SCARRING, EXUBERANT GRANULATION TISSUE, PSEUDOBURSA, RECURRENCE, MESH MIGRATION, AND BOWEL ADHERENT TO MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, REMOVAL OF MESH, EXCISIONAL DEBRIDEMENT OF ABSCESS WITH COMPLEX CLOSURE, LYSIS OF ADHESIONS, AND REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Hematoma; Hernia; Inflammation; Necrosis; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11904598 ↗
• MalfunctionApr 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ABDOMINAL WALL REPAIR PROCEDURE, THE DEVICE HAD A VISIBLE TEAR IN THE FABRIC. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698640 ↗
• InjuryApr 30, 2020Mechanics 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 PAIN, ABDOMINAL PAIN, GASTROINTESTINAL MALFUNCTION, GROTESQUE SWELLING, SCARRING, DISFIGUREMENT, MESH FAILED, DEFECTIVE DEVICE, LOSS OF ENJOYMENT OF LIFE, PHYSICAL DISABILITY, LOSS OF PHYSICAL, MENTAL AND EMOTIONAL HEALTH, SCAR TISSUE, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY, HERNIA REPAIR WITH NEW MESH, AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Emotional Changes; Hernia; Injury; No Code Available; Pain; Scar Tissue; Scarring; Swelling; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10014444 ↗
• InjuryApr 6, 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE AND BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Constipation; Erosion; Hernia; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9928334 ↗
• MalfunctionOct 14, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) PROCEDURE, ON THE ABDOMINAL WALL, THE SUTURES ADHERING THE MESH BROKE OFF IN SITE WHEN IT WAS TOUCHED USING ATRAUMATIC LAPAROSCOPIC CLAMPS. THE MESH WAS FIXED USING A TACKER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9183969 ↗
• InjuryOct 3, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS TO BOWEL AND SMALL INTESTINE, RECURRENCE, MESH DETACHMENT, HEMATOMA, SWELLING, MESH FORMED SLING CONFIGURATION, LIQUIFIED BLOOD, PAIN, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Pain; Swelling; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 9153475 ↗
• InjuryMar 29, 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 AN UMBILICAL HERNIA, VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPY THAT SHOWED ADHESIONS OF 2 LOOPS OF SMALL BOWEL TO THE ABDOMINAL WALL MESH AND GENTLE DISSECTION WAS USED TO TAKE THE SMALL BOWEL OFF OF THE MESH.

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

  MAUDE report 8465695 ↗
• InjuryApr 4, 2018Loss 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A REPAIR OF INCARCERATED AND RECURRENT VENTRAL HERNIA WITH MESH IMPLANTATION. HE HAD REVISION SURGERY 8 YEARS AND 3 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED PAIN, ADHESIONS, LACK OF INCORPORATION, REHERNIATION, MESH MIGRATION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Ascites; Fistula; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Scarring; Seroma; Swelling/ Edema; Unspecified Tissue Injury; Vascular Dissection

  MAUDE report 7395796 ↗