Parietex PCO4VP (UDI 10884521514140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10884521514140), received between Sep 21, 2017 and Apr 24, 2026 — classified as 3 deaths, 99 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (43 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 121 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UMBILICAL HERNIA (REPORTED AS 8 MM) WAS TREATED WITH ROBOTIC-ASSISTED SURGERY AND IMPLANTATION OF A PROSTHESIS MESH AT THE NAVEL/UMBILICAL AREA. APPROXIMATELY 2 TO 3 WEEKS AFTER THE PROCEDURE, PERSISTENT POST-OPERATIVE PAIN WAS REPORTED, AND ANTI-INFLAMMATORIES WERE GIVEN WITH AN EXPECTATION THAT SYMPTOMS WOULD FADE OVER 6 MONTHS TO 1 YEAR. AT APPROXIMATELY 6 MONTHS POST-PROCEDURE, THE PAIN REPORTEDLY HAD NOT IMPROVED, AND A RADIOLOGY EVALUATION WAS PERFORMED IN WHICH THE RADIOLOGIST STATED THAT EVERYTHING WAS FINE. THE PATIENT LATER RETURNED TO THE SURGEON AND WAS REPORTEDLY DIAGNOSED WITH A PAINFUL SCAR, DESCRIBED AS A RARE SIDE EFFECT (~5%), AND IT WAS STATED THAT THE MESH/PROSTHESIS WAS IMPOSSIBLE TO REMOVE; INJECTIONS WERE OFFERED BUT WERE STATED TO NOT ALWAYS WORK. THE PATIENT REPORTED ONGOING SYMPTOMS FOR APPROXIMATELY 5 YEARS, INCLUDING BURNING SENSATION AT/AROUND THE NAVEL, SKIN SENSITIVITY TO CLOTHING/FABRICS RUBBING THE NAVEL AREA, PERMANENT DISCOMFORT AT THE SURGICAL/IMPLANT SITE, THROBBING PAIN, AND PAIN/SENSITIVITY TO TOUCH. ADDITIONAL IMPACTS INCLUDED POSITION-RELATED SLEEP DISORDER, LOW MOOD, DIFFICULTY DOING SPORTS, DIFFICULTY SITTING FOR L

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Contact Dermatitis; Depression; Discomfort; Malaise; Pain; Unintended Radiation Exposure

  MAUDE report 24991070 ↗
• MalfunctionMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY, FOLLOWING THE INSTALLATION OF THE MESH FOR THE TREATMENT OF AN UMBILICAL HERNIA, THE PATIENT EXPERIENCED VIOLENT AND DAILY PAIN, BURNS, STABBING SENSATIONS, TINGLING, AND NAUSEA.

  Patient problems: Burning Sensation; Pain

  MAUDE report 24613149 ↗
• InjuryMar 11, 2026Migration 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 24571895 ↗
• InjuryFeb 19, 2026Adverse 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 recurrence, infection, pain, suffering and emotional distress. Post-operative patient treatment included revision surgery, umbilical hernia repair and mesh removal.

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

  MAUDE report 24393934 ↗
• MalfunctionFeb 16, 2026Degraded

  IT WAS REPORTED THAT DURING A PROCEDURE, THE MESH WAS FOUND TO BE UNRAVELING, FRAYING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24356976 ↗
• MalfunctionJan 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE MESH WAS OPENED FOR AN OPEN UMBILICAL HERNIA PROCEDURE, THE MESH WAS FLAKING AND CLEAR BITS WERE LOOSE FROM THE MESH. AFTER SOAKING THE MESH IN SALINE, MORE OF THE CLEAR LAYER DETACHED. THE MESH WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952183 ↗
• MalfunctionJun 19, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ACCORDING TO THE REPORTER, DURING A HERNIA SURGERY, WHEN THE MESH WAS OPENED, IT WOULD NOT LAY CORRECTLY WHERE IT NEEDED TO BE. THE MESH KEPT ON CURLING AND NOT LAYING FLAT. A NEW MESH OF THE SAME SIZE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293403 ↗
• MalfunctionMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SINCE THE OPERATION, THE PATIENT HAD PERSISTENT PAIN IN THE NAVEL. THE FREQUENCY OF PAIN IS ON AVERAGE ONCE A WEEK.

  Patient problems: Pain

  MAUDE report 21701348 ↗
• MalfunctionMar 19, 2025Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE, THE MESH BEGAN TO DISINTEGRATE WHEN IMPLANTED. A NEW MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642959 ↗
• InjuryFeb 12, 2025Migration 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21368240 ↗
• InjuryJan 10, 2025Migration 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 MIGRATE, PAIN, RECURRENCE, ADHESIONS, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MEDICATION.

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

  MAUDE report 21132203 ↗
• InjuryNov 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, PROSTATE ISSUES, PAIN IN UMBILICAL AREA, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED A MICROWAVE PROCEDURE TO TREAT PROSTATE.

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

  MAUDE report 20659757 ↗
• MalfunctionOct 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN UMBILICAL HERNIA REPAIR, UPON IMPLANTING THE HERNIA MESH, AS SOON AS THE SURGEON TRIED TO PLACE THE MESH, THE COLLAGEN FILM OF THE TOP PART CAME OFF; THE SURGEON ATTEMPTED TO IMPLANT THE MESH BUT WAS NOT SATISFIED, SO TOOK IT OUT AND DISCARDED. THIS WAS WITHOUT ANY FORCE OR EFFORT. THE USER CLOSED THE DEFECT WITHOUT THE USE OF A MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20574498 ↗
• MalfunctionOct 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE, WHILE IMPLANTING THE MESH. THE COMPOSITE PART OF THE MESH CAME OFF WITHOUT ANY EXCESS FORCE. TO RESOLVE THE ISSUE, THE SURGEON DID NOT USE A MESH AND ENDED UP SUTURING THE DEFECT INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568184 ↗
• InjurySep 17, 2024Migration 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 THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MESH MIGRATION, ABDOMINAL PAIN, RECURRENCE, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20239522 ↗
• MalfunctionAug 13, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE MESH WAS BUNCHING UP ON ITSELF AND COULD NOT BE SEWN TO THE TISSUE. THE SURGEON USED A COMPETITOR'S DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974054 ↗
• MalfunctionAug 13, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE MESH WAS BUNCHING UP ON ITSELF AND COULD NOT BE SEWN TO THE TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19972250 ↗
• InjuryAug 9, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ILEUS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, BILATERAL MYOSFASCIAL FLAP ROTATION.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19954772 ↗
• InjuryAug 9, 2024Mechanics 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19953742 ↗
• InjuryJul 23, 2024Mechanics 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19812288 ↗
• InjuryJun 4, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19462408 ↗
• InjuryApr 23, 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 OBSTRUCTION, PAIN, INFLAMMATION, ABDOMINAL PAIN, AND DIARRHEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPAIR OF VENTRAL HERNIA WITH MESH UNDERLAY AND OVERLAY, AND MEDICATION.

  Patient problems: Abdominal Pain; Diarrhea; Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 19165780 ↗
• InjuryMar 26, 2024Mechanics 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, INFECTION, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

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

  MAUDE report 18980753 ↗
• DeathMar 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE COLLAGEN BARRIER OF THE MESH CRACKED OFF WHEN THE USER FOLDED IT. THE MESH WAS NOT IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 18852630 ↗
• InjuryFeb 28, 2024Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, MESH EROSION, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 18804277 ↗