Parietex PCO15FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521179783), received between Dec 14, 2017 and Mar 26, 2026 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN INTERVENTION BY A LAPAROSCOPIC PROSTHETIC REINFORCEMENT AND AN EVENTRATION ON UMBILICAL SCAR EXTRACTION, WHICH CONTAINED ADHESIONS THAT WERE METICULOUSLY RELEASED, THE PATIENT WAS HAVING SHARP PAINS IN THE STOMACH WITH PERSISTENT DIARRHEA DURING THE DAY. THESE PAINS WERE MORE ACUTE AND CONSTANT, PREVENTING THE PATIENT FROM WORKING ON CERTAIN DAYS AND WAKING UP AT NIGHT. THE PATIENT¿S CONDITION WAS DETERIORATING DAY BY DAY, AND NO SOLUTION WAS OFFERED. THE PATIENT HAD TWO INGUINAL HERNIA SURGERIES IN 2019.

  Patient problems: Abdominal Pain; Diarrhea; Sleep Dysfunction

  MAUDE report 24699394 ↗
• MalfunctionFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, FOLLOWING A HYSTERECTOMY, THE PATIENT EXPERIENCED DAILY ABDOMINAL PAIN AND UNDERWENT REPEATED ABDOMINAL SCANS.

  Patient problems: Abdominal Pain

  MAUDE report 24232745 ↗
• InjuryJan 16, 2026Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, UNINCORPORATED MESH, RECURRENCE, INFECTION, ABSCESS, ADHESIONS, BOWEL OBSTRUCTION, PAIN, ISCHEMIA, BLOOD LOSS, ANEMIA, NECROSIS, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HOSPITALIZATION, SMALL BOWEL RESECTION, PARTIAL OMENTECTOMY, ABDOMINAL WASHOUT.

  Patient problems: Abscess; Adhesion(s); Anemia; Distress; Hemorrhage/Blood Loss/Bleeding; Hernia; Ischemia; Necrosis; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24097491 ↗
• InjurySep 20, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMEN PAIN, TEARING SENSATION, ABDOMEN TOO HOT TO TOUCH, CANNOT MOVE WITH OUT EXTREME STABBING PAIN, TENDERNESS, NAUSEA, WEAKNESS IN LEGS, FIBROMYALGIA, EXHAUSTED, <(>&<)> NEUROPATHIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, <(>&<)> MEDICATION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fatigue; Muscle Weakness/Atrophy; Nausea; Neuropathy; Pain; Unspecified Tissue Injury

  MAUDE report 20273241 ↗
• InjurySep 12, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20202308 ↗
• 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A SPIGELIAN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, BLOATING, PULLING/RIPPING SENSATION, TIREDNESS, AND SCARRING. POST OPERATIVE PATIENT TREATMENT INCLUDED HOSPITAL ADMISSION, LAPAROTOMY WITH OPEN ADHESIOLYSIS, REPAIR OF ENTEROTOMY, AND ORAL MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Discomfort; Fatigue; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20158636 ↗
• 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NUMBNESS, PINS AND NEEDLES SENSATION, BURNING SENSATION, AND DISTURBED SLEEP. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Burning Sensation; Discomfort; Numbness; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 20141412 ↗
• 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH BREAK DOWN, MESH FAILURE, HERNIA RECURRENCE, CHRONIC PAIN, SCARRING, DISFIGUREMENT, DEVICE DEFECTIVE, CHRONIC FATIGUE, PSYCHOLOGICAL AND 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: Deformity/ Disfigurement; Emotional Changes; Fatigue; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 15838809 ↗
• InjuryJan 28, 2022Migration 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, LOSS OF ENJOYMENT OF LIFE, INABILITY TO PARTICIPATE IN PREVIOUS ACTIVITIES, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, MEDICATION, THERAPY, REHABILITATION, AND REST.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Chills; Discomfort; Emotional Changes; Erythema; Fever; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13385778 ↗
• MalfunctionOct 24, 2020Break; Insufficient Device Problem Information; Material Split, Cut or Torn; Break; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE INSERTING THE DEVICE INTO THE PATIENT, THE DEVICE WAS BREAKING THE MESH TRACK. A CONSOLIDATION HAD TO BE DONE USING AN ANCILLARY WIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10731652 ↗
• InjuryFeb 28, 2020Adverse 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EXTENSIVE ADHESIONS AND PAIN. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 9770679 ↗
• InjurySep 2, 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 A VENTRAL WALL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE OF PARASTOMAL HERNIA, SYMPTOMATIC INCISIONAL HERNIA, SEVERE PAIN, BOWEL ADHESIONS, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, BLOATING, SCAR TISSUE, SMALL BOWEL OBSTRUCTION, AND LOSS OF APPETITE. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISIONAL AND PARASTOMAL HERNIA REPAIR, ENTEROTOMY, WITH REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Chills; Decreased Appetite; Diarrhea; Discomfort; Hernia; Inflammation; Injury; Nausea; No Code Available; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 8954004 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST INCISIONAL HERNIA, THE MESH STARTED GIVING THE PATIENT SHARP STABBING PAINS STRAIGHT AWAY BUT WAS TOLD THAT IT WAS OKAY. IT FAILED AND WAS STUCK IN THE PATIENT'S BOWEL THEN MORE MESH WAS INSERTED LAPAROSCOPY. THE SURGEON PEEL THE MESH ON THE BOWELS BUT THE PAIN STARTED AGAIN ON THE PATIENT'S BOWELS. THE PATIENT HAD AN OPERATION TO RECONSTRUCT THE ABDOMEN AND WAS FOUND THAT HER BOWELS WERE STUCK WITH MESH. THE SURGEON SAID "I PICKED OUT WHAT I COULD OF THE MESH AND HAVEN'T PUT ANY MORE IN". CURRENTLY, THE PATIENT HAVE AN EXTREMELY LARGE HERNIA THAT NOBODY WANTS TO TOUCH BECAUSE OF A BURST APPENDIX AND MESH. IT WAS ALSO REPORTED THAT THIS HER AUTOIMMUNE SYSTEM. SHE SUFFERED CHRONIC FLU SYMPTOMS DAILY, BONE AND JOINT PAIN, HAIR LOSS, DEPRESSION AND VISION WAS WORSE.

  Patient problems: Depression; Hair Loss; No Code Available; Pain; Visual Impairment

  MAUDE report 8546763 ↗
• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 14 MONTHS FOLLOWING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) FOR AN UMBILICAL HERNIA, THE PATIENT EXPERIENCED EPIGASTRIC PAIN WHICH LED TO A HOSPITALIZATION FOR LAPAROSCOPY ON (B)(6) 2017 AND AGAIN ON (B)(6) 2019. THE PATIENT HAD CHRONIC PERITONITIS, FIBROSIS PLATES ON LIVER AND COLON WHICH HAS CONTACT TO MESH AND GRANULOMATOUS INFLAMMATION WITH MESOTHELIAL H YPERPLASIA. IT WAS STATED THAT THERE WERE NO PROBLEMS DURING THE ORIGINAL PROCEDURE.

  Patient problems: Fibrosis; Granuloma; Hyperplasia; No Code Available; Pain; Peritonitis

  MAUDE report 8441810 ↗
• InjuryJun 7, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A LAPAROSCOPIC UMBILICAL HERNIA, UPON IMPLANTATION, THE MESH WAS FOLDED AT THE EXPANDERS JUNCTION ON FASCIAL SIDE AGAINST FASCIAL SIDE, AND THE VIOLET EXPANDERS WERE BROKEN. THE WOUND WAS CLOSED AFTER THE PROCEDURE BY SUTURING AND THERE WERE TWENTY SIX FIXATION POINTS APPLIED. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM AND RE OPERATION WAS NEEDED. THE INCISION WAS EXTENDED MORE THAN 1 INCH. THE EVENT LEAD TO OR EXTENDED THE PATIENT'S HOSPITALIZATION FOR FIVE DAYS.

  Patient problems: No Code Available

  MAUDE report 7577849 ↗
• InjuryJan 11, 2018Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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 VENTRAL HERNIA REPAIR WITH MESH. SHE HAD REVISION SURGERY 3 YEARS AND 11 MONTHS POST-SURGERY. THE PATIENT UNDERWENT A ROBOTIC ASSISTED LYSIS OF ADHESIONS VENTRAL HERNIA REPAIR WITH MESH AND REMOVAL OF OLD MESH. THE PATIENT EXPERIENCED SURGICAL REVISION, RECURRENT HERNIA, LYSIS OF ADHESIONS DUE TO EXTENSIVE INTRA-ABDOMINAL ADHESIONS, ABDOMINAL PAIN, HOLE IN MESH NEAR INCARCERATED OMENTUM, AND PAIN.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Inflammation; Injury; Muscle Weakness/Atrophy; No Code Available; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 7182997 ↗
• 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. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, HIGH LEVELS OF HERNIA RECURRENCE, ABDOMINAL WALL ABSCESS, PURULENT DISCHARGE, NECROTIC REGION IN ABDOMINAL WALL AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, REPAIR OF INCISIONAL HERNIA, DRAINAGE OF ABDOMINAL WALL ABSCESS AND PARTIAL EXCISION OF MESH.

  Patient problems: Abscess; Adhesion(s); Hernia; Injury; Necrosis; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7116830 ↗