ParietexRecalls & reported problems across all models

We found 73 models of Parietex by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 5,392 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2016 and Sep 25, 2026 — classified as 47 deaths, 5,238 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1,585 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Parietex problems

Parietex models

73 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Parietex PCO12X

  Mesh, surgical, polymeric
  3 deaths446 reports
• Parietex PCO9X

  Mesh, surgical, polymeric
  1 death446 reports
• Parietex PCO2015X

  Mesh, surgical, polymeric
  1 death364 reports
• Parietex PCO1510X

  Mesh, surgical, polymeric
  3 deaths340 reports
• Parietex PCO15X

  Mesh, surgical, polymeric
  1 death305 reports
• Parietex TECT1510AR

  Mesh, surgical, polymeric
  2 deaths283 reports
• Parietex TECT1510AL

  Mesh, surgical, polymeric
  1 death255 reports
• Parietex PCO2520X

  Mesh, surgical, polymeric
  5 deaths239 reports
• Parietex PCO6VP

  Mesh, surgical, polymeric
  1 death205 reports
• Parietex TECR1510

  Mesh, surgical, polymeric
  199 reports
• Parietex PCO8VP

  Mesh, surgical, polymeric
  1 death172 reports
• Parietex PCO4VP

  Mesh, surgical, polymeric
  3 deaths121 reports
• Parietex PCO3020X

  Mesh, surgical, polymeric
  3 deaths110 reports
• Parietex PNP6X3

  Mesh, surgical, polymeric
  109 reports
• Parietex PCO1510OSX

  Mesh, surgical, polymeric
  2 deaths108 reports
• Parietex PCO20X

  Mesh, surgical, polymeric
  3 deaths106 reports
• Parietex PCO4VP

  Mesh, surgical, polymeric
  99 reports
• Parietex PCO2015OSX

  Mesh, surgical, polymeric
  95 reports
• Parietex PCO8VP

  Mesh, surgical, polymeric
  1 death90 reports
• Parietex TEC1510

  Mesh, surgical, polymeric
  2 deaths86 reports
• Parietex PNP8X3

  Mesh, surgical, polymeric
  85 reports
• Parietex PCO3728X

  Mesh, surgical, polymeric
  3 deaths82 reports
• Parietex TET1515

  Mesh, surgical, polymeric
  2 deaths72 reports
• Parietex TET1309

  Mesh, surgical, polymeric
  67 reports
• Parietex TECR1515

  Mesh, surgical, polymeric
  65 reports
• Parietex TET3030

  Mesh, surgical, polymeric
  1 death61 reports
• Parietex PCO2520OSX

  Mesh, surgical, polymeric
  58 reports
• Parietex TEC1309

  Mesh, surgical, polymeric
  1 death58 reports
• Parietex TECT1510ADPR

  Mesh, surgical, polymeric
  51 reports
• Parietex TECT1510ADPL

  Mesh, surgical, polymeric
  48 reports
• Parietex TEC1515

  Mesh, surgical, polymeric
  44 reports
• Parietex TCM1510X3

  Mesh, surgical, polymeric
  38 reports
• Parietex PCO6VP

  Mesh, surgical, polymeric
  37 reports
• Parietex TET2020

  Mesh, surgical, polymeric
  2 deaths36 reports
• Parietex PCO2H3

  Mesh, surgical, polymeric
  1 death30 reports
• Parietex PCO8OSX

  Mesh, surgical, polymeric
  1 death24 reports
• Parietex PCO12FX

  Mesh, surgical, polymeric
  24 reports
• Parietex PCOPM20

  Mesh, surgical, polymeric
  1 death23 reports
• Parietex TET1309D

  Mesh, surgical, polymeric
  23 reports
• Parietex PCO3020OSX

  Mesh, surgical, polymeric
  21 reports
• Parietex PCOPM15

  Mesh, surgical, polymeric
  17 reports
• Parietex PCO15FX

  Mesh, surgical, polymeric
  17 reports
• Parietex PCO1510FX

  Mesh, surgical, polymeric
  15 reports
• Parietex PCO9FX

  Mesh, surgical, polymeric
  15 reports
• Parietex PCO2015FX

  Mesh, surgical, polymeric
  14 reports
• Parietex PCO2520FX

  Mesh, surgical, polymeric
  14 reports
• Parietex TEC3030

  Mesh, surgical, polymeric
  14 reports
• Parietex TECT1510ADP2R

  Mesh, surgical, polymeric
  13 reports
• Parietex PCOPM15H35

  Mesh, surgical, polymeric
  1 death12 reports
• Parietex TCM1515X3

  Mesh, surgical, polymeric
  12 reports
• Parietex PCO3020FX

  Mesh, surgical, polymeric
  12 reports
• Parietex TECT1510ADP2L

  Mesh, surgical, polymeric
  12 reports
• Parietex TECT1612AL

  Mesh, surgical, polymeric
  12 reports
• Parietex TET1510

  Mesh, surgical, polymeric
  10 reports
• Parietex TECT1612AR

  Mesh, surgical, polymeric
  1 death9 reports
• Parietex TEC2020

  Mesh, surgical, polymeric
  8 reports
• Parietex TCM1106X3

  Mesh, surgical, polymeric
  7 reports
• Parietex TCM3030

  Mesh, surgical, polymeric
  6 reports
• Parietex TECT1612AFR

  Mesh, surgical, polymeric
  6 reports
• Parietex TET5050

  Mesh, surgical, polymeric
  6 reports
• Parietex PCOPM15H50

  Mesh, surgical, polymeric
  5 reports
• Parietex PCO2H1

  Mesh, surgical, polymeric
  5 reports
• Parietex TEC1410DP

  Mesh, surgical, polymeric
  5 reports
• Parietex PCO20FX

  Mesh, surgical, polymeric
  4 reports
• Parietex PCO2H4

  Mesh, surgical, polymeric
  3 reports
• Parietex TCM4530

  Mesh, surgical, polymeric
  3 reports
• Parietex TECR1410DP2

  Mesh, surgical, polymeric
  3 reports
• Parietex TCM2020

  Mesh, surgical, polymeric
  2 reports
• Parietex TEC1410P5

  Mesh, surgical, polymeric
  2 reports
• Parietex TCM1515

  Mesh, surgical, polymeric
  1 report
• Parietex PCO3728FX

  Mesh, surgical, polymeric
  1 report
• Parietex TECR1510AL

  Mesh, surgical, polymeric
  1 report
• Parietex TECR3030

  Mesh, surgical, polymeric
  1 report

Recent Parietex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50903382 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50618947 ↗
• DeathAug 20, 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 an inguinal hernia. It was reported that after implant, the patient experienced nerve damage, pain, suffering, emotional distress, death. Post-operative patient treatment included revision surgery. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.

  Patient problems: Distress; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 50356563 ↗
• DeathAug 20, 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 hernia. It was reported that after implant, the patient experienced emotional distress, death. Post-operative patient treatment included revision surgery. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.

  Patient problems: Distress; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 50356531 ↗
• InjuryAug 12, 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 hernia. It was reported that after implant, the patient experienced emotional distress. Post-operative patient treatment included revision surgery.

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

  MAUDE report 50227394 ↗
• 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 ↗
• InjuryJul 30, 2026Adverse 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 incisional hernia. It was reported that after implant, the patient experienced mesh failure, recurrence, pain, adhesions, and obstruction. Post-operative patient treatment included removal of mesh, and hernia repair.

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

  MAUDE report 50089738 ↗
• InjuryJul 27, 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 incisional hernia. It was reported that after the implant, the patient experienced pain, hernia recurrence, adhesions, obstructions, & GI issues. Post-operative patient treatment included exploratory laparotomy, lysis of adhesions, component release, & hernia repair with mesh.

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

  MAUDE report 50048114 ↗
• InjuryJul 8, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PAIN, INFECTION, INFLAMMATION, FISTULA, SEROMA, PERFORATION, MESH EROSION, ABSCESS, CHRONIC DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC PLACEMENT, MEDICATION, WOUND DEBRIDEMENT, & USE OF BLAKE DRAIN.

  Patient problems: Abscess; Adhesion(s); Erosion; Fistula; Fluid Discharge; Hernia; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25752730 ↗
• InjuryJul 8, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PAIN, INFECTION, INFLAMMATION, FISTULA, SEROMA, PERFORATION, MESH EROSION, ABSCESS, CHRONIC DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, WOUND VAC PLACEMENT, MEDICATION, HERNIA REPAIR WITH, WOUND DEBRIDEMENT, & USE OF BLAKE DRAIN.

  Patient problems: Abscess; Adhesion(s); Erosion; Fistula; Fluid Discharge; Hernia; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25752693 ↗
• InjuryJun 15, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, NERVE DAMAGE, PAIN, SUFFERING, INFECTION, HYDROCELE, SCARRING, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LEFT ORCHIECTOMY WITH TESTICULAR PROSTHESIS, ILIOINGUINAL INJECTIONS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25512815 ↗
• InjuryJun 11, 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 AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25473329 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MESH ROUND 15 CM POLYPROPYLENE PROSTHESIS WAS IMPLANTED AT THE UMBILICAL ABDOMINAL WALL DURING A LAPAROSCOPIC PROCEDURE FOR AN UMBILICAL HERNIA, AND THAT ABOUT ONE MONTH AFTER THE OPERATION THE PATIENT EXPERIENCED RECURRENT UMBILICAL HERNIA/UMBILICAL RECURRENCE, AN EVENTRATION ORIFICE NOTED INTRAOPERATIVELY, CHRONIC UNBEARABLE ABDOMINAL PAIN AT THE NAVEL/PROSTHESIS LOCATION (INCLUDING PAIN AFTER WALKING ABOUT 100 METERS THAT DECREASED WHEN LYING ON THE BACK), BACK PAIN, A BURNING SENSATION IN CONTACT WITH CLOTHING, NECROSIS INCLUDING FAT NECROSIS, SCAR STIGMATA WITH IRREGULARITY OF THE SCAR PATH, SPLENOMEGALY, WEIGHT LOSS OF MORE THAN 13 KG, RETRACTION OF THE NAVEL, AND A SUBUMBILICAL SEROMA THAT WAS EXTREMELY SENSITIVE TO PALPATION, WITH FUNCTIONAL IMPAIRMENT INCLUDING INABILITY TO WORK AND BEING UNABLE TO DO ANYTHING FOR SIX AND A HALF MONTHS. MOREOVER, MULTIPLE COMPUTED TOMOGRAPHY SCANS, ULTRASOUNDS, AND MRIS WERE REPORTED BY THE PATIENT. AN ABDOMINAL WALL ULTRASOUND PERFORMED FOR PAIN AND PALPATION OF A SUPRAUMBILICAL MASS DEMONSTRATED A LATERALIZED SUPRAUMBILICAL NODULAR ECHOGENIC INFILTRATION MEASURING 21 MM X 10 MM WITH A CENTRAL FLUID IMAGE OF 9 MM, WIT

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Back pain; Burning Sensation; Hernia; Necrosis; Scar Tissue; Seroma; Unintended Radiation Exposure; Weight Changes

  MAUDE report 25404531 ↗
• InjuryJun 4, 2026Adverse 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH AND MESH REVISION.

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

  MAUDE report 25394919 ↗
• 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 ↗

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