Parietex PCO1510XRecalls & reported problems

Summary

The FDA's MAUDE database contains 340 adverse event reports that list this exact device (DI 10884521179707), received between Sep 19, 2017 and Jul 30, 2026 — classified as 3 deaths, 337 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (105 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 25 most recent of 340 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse 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, infection, recurrence, inflammation, adhesions, obstruction, perforation, sepsis, abscess, bowel injury, acute kidney injury, open wound. Post-operative patient treatment included bowel resection, repair of enterotomies, mesh removal, hernia repair, drainage of abscess, bilateral myocutaneous flaps, and incision and drainage of abscess.

  Patient problems: Abscess; Adhesion(s); Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Perforation; Renal Failure; Sepsis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 50089928 ↗
• InjuryJun 3, 2026Adverse 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 A I NCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25385745 ↗
• InjuryNov 3, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Distress; Hernia; Unspecified Tissue Injury

  MAUDE report 23458186 ↗
• InjuryOct 1, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23196691 ↗
• InjuryMar 18, 2025Migration 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 MESH BUNCHING, MESH NOT ADHERENT, PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, CONSTIPATION, AND VOMITING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 21635487 ↗
• InjuryFeb 18, 2025Adverse 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A P ARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, ADHESIONS, OBSTRUCTION, LABS ABNORMAL FOR WBC, TACHYCARDIA, CONFUSION, ABDOMINAL PAIN, WEAKNESS WITHIN ANTERIOR FASCIA, SMALL PERFORATION ON BOWEL, SEROSAL TEARS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, HOSPITALIZATION, EXPLORATORY LAP, PRIMARY HERNIA REPAIR, SEROSAL TEARS REPAIR, TRANSFERRED TO ICU.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Confusion/ Disorientation; Hernia; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Perforation; Tachycardia; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21400618 ↗
• InjuryJan 27, 2025Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILED INCORPORATION, PAIN, RECURRENCE, ADHESIONS, BLEEDING, INCARCERATED OMENTUM, AND ABDOMINAL DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH AND HERNIA REPAIR WITH BILATERAL COMPONENT RELEASE.

  Patient problems: Adhesion(s); Discomfort; Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 21242941 ↗
• InjuryDec 9, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 MESH MIGRATION, RECURRENCE, INFECTION, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20885237 ↗
• InjuryNov 14, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, HEMATOMA, INFLAMMATION, ADHESIONS, DISCOMFORT, SWELLING, & PULLING FEELING.

  Patient problems: Adhesion(s); Discomfort; Hematoma; Hernia; Inflammation; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 20686096 ↗
• InjuryNov 7, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; 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 THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MIGRATION, PAIN, INFLAMMATION, SWELLING, IRRITATION, HERNIA, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Hernia; Inflammation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 20631531 ↗
• InjuryOct 1, 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, ADHESIONS, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20347901 ↗
• InjurySep 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, HEMATOMA, INFLAMMATION, ADHESIONS, SEROMA, CONSTIPATION. POST-OPERATIVE TREATMENT INCLUDES USE OF STOOL SOFTENER.

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

  MAUDE report 20163259 ↗
• InjuryJul 31, 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 INFLAMMATION, HERNIA, ADHESIONS, ABDOMINAL PAIN, PULLING SENSATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, ADDITIONAL MESH IMPLANT, MEDICATION.

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

  MAUDE report 19873414 ↗
• InjuryJul 25, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; 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 THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ABDOMINAL PAIN, ADHESIONS, DISRUPTED MESH, & NAUSEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED ULTRASOUND, CAT SCAN, HERNIA REPAIR WITH MESH, MESH REVISION/PARTIAL MESH REMOVAL, IV FLUIDS, IV ANALGESIA, IV ANTI-NAUSEA MEDICATION, & USE OF ABDOMINAL BINDER.

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

  MAUDE report 19832831 ↗
• InjuryJun 25, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, MILD SKIN REDNESS, HERNIA RECURRENCE, ABDOMINAL PAIN, BOWEL OBSTRUCTION, & ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ANTIBIOTICS, HERNIA REPAIR WITH MESH, & CT SCAN.

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

  MAUDE report 19610910 ↗
• InjuryApr 26, 2024Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 MESH MIGRATION, RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 19194174 ↗
• InjuryMar 11, 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 ABSCESS, CHRONIC PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Discomfort; Pain; Unspecified Tissue Injury

  MAUDE report 18876358 ↗
• InjuryMar 7, 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, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 18862845 ↗
• InjuryMar 7, 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 AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 18862765 ↗
• InjuryJan 25, 2024Adverse 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SCARRING, HERNIA, ERODING MESH DAMAGED BOWEL, OPEN WOUND, INFECTION, MESH EROSION INTO VISCERA AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED RIGHT HEMICOLECTOMY, MEDICATION, WOUND VAC, DEBRIDEMENT, SMALL BOWEL RESECTION AND DISSECTED MESH.

  Patient problems: Adhesion(s); Erosion; Hernia; Impaired Healing; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18584342 ↗
• InjuryDec 27, 2023Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, INFLAMMATION, RECURRENCE, ADHESIONS, SCARRING, CONSTIPATION, DISTENTION, ACID REFLUX, MESH ENCAPSULATION, LACK OF ADEQUATE INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Foreign Body Reaction; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18400969 ↗
• InjuryOct 31, 2023Adverse 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 INFECTION, ADHESIONS, PAIN, CHRONIC INFLAMMATION, SCARIFICATION, AND LACK OF ADEQUATE INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Burning Sensation; Cramp(s) /Muscle Spasm(s); Discomfort; Foreign Body Reaction; Impaired Healing; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18043214 ↗
• InjuryOct 24, 2023Adverse 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 RECURRENCE, ADHESIONS, PAIN, MESH EROSION, AND SMALL BOWEL PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Diarrhea; Emotional Changes; Erosion; Hernia; Obstruction/Occlusion; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17998907 ↗
• InjuryOct 20, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, INFLAMMATION, ADHESIONS, ABDOMINAL PAIN, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 17978227 ↗
• InjuryAug 16, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; 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 THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, SMALL BOWEL OBSTRUCTION, PAIN, MESH MIGRATION, AND MESH PULLED AWAY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND LYSIS OF ADHESIONS.

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

  MAUDE report 17561491 ↗