Symbotex SYM20Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521593435), received between Dec 3, 2018 and Apr 28, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (11 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 28, 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 25019583 ↗
• InjuryJun 16, 2025Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, MESH BALLED, PAIN, INFECTION, INFLAMMATION, ADHESIONS, FISTULA, EMOTIONAL CHANGES, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Fistula; Inflammation; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22214835 ↗
• InjuryJun 11, 2025Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, MESH BALLED, PAIN, INFECTION, INFLAMMATION, ADHESIONS, FISTULA, EMOTIONAL CHANGES, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Fistula; Inflammation; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22190821 ↗
• InjuryJul 14, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, ADHESIONS, INFLAMMATION, ABDOMINAL PAIN, DISCOMFORT, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. 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; Necrosis; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 17326138 ↗
• InjuryMar 9, 2023Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, ADHESIONS, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Emotional Changes; Hematoma; Hernia; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16513005 ↗
• InjuryFeb 17, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; 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. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SUFFERING, DEFECTIVE MESH, HOLE IN MESH, PAIN, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, RECURRENCE, OBSTRUCTION, ADHESIONS, SEROSAL TEAR, PROTRUSION OF COLON AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH ADDITIONAL MESH, SEROSAL TEAR REPAIR, EXPLORATORY LAPAROTOMY, REVISION SURGERY, CT SCAN, TAKEDOWN OF ADHESIONS AND VENTRAL HERNIA REPAIR.

  Patient problems: Abdominal Distention; Adhesion(s); Distress; Emotional Changes; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 16397489 ↗
• InjuryJan 17, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; 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. THE PRODUCT WAS USED FOR THERAPEUTIC LAPAROSCOPIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SCARRING, SCAR TISSUE, SEROMA, NAUSEA, VOMITING, STRANDING AROUND LOOP OF BOWEL, SUFFERING, DEFECTIVE MESH, HOLE IN MESH, PAIN, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, RECURRENT HERNIA WITH INCARCERATION, OBSTRUCTION, ADHESIONS, SEROSAL TEAR, PROTRUSION OF COLON AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, SCAR REVISION, APPLICATION OF PREVENA DRESSING, HERNIA REPAIR WITH ADDITIONAL MESH, SEROSAL TEAR REPAIR, EXPLORATORY LAPAROTOMY, REVISION SURGERY, CT SCAN, TAKEDOWN OF ADHESIONS AND VENTRAL HERNIA REPAIR.

  Patient problems: Abdominal Distention; Adhesion(s); Distress; Emotional Changes; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 16185301 ↗
• InjuryApr 6, 2022Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; Material Integrity 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 RECURRENCE, MESH EVENTRATION, ADHESIONS, PAIN, DISCOMFORT, INFLAMMATION, MESH MIGRATION, SCARRING, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

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

  MAUDE report 14026257 ↗
• InjuryAug 19, 2021Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Degraded; Migration or Expulsion of Device; 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. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN, RECURRENCE, FLUSHING/LIGHTHEADEDNESS, NOT PASSING FLATULENCE, PAIN, CRAMPING, LOW POTASSIUM, SWELLING, TENDERNESS, ADHESIONS, NAUSEA, VOMITING, NONOBSTRUCTIVE BOWEL GAS PATTERN, AND MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TREATED WITH INTRAVENOUS FLUIDS/POTASSIUM/PAIN MEDICATIONS, LYSIS OF ADHESIONS, REMOVAL OF MESH, BILATERAL OPEN MYOFASCIAL ADVANCEMENT FLAP, HERNIA REPAIR WITH MESH. IT WAS NOTED THAT THE PATIENT WAS DISCHARGED FROM HOSPITAL WITH READMISSION RISK SCORE OF 19 (HIGHEST POSSIBLE SCORE).

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Foreign Body In Patient; Hernia; Nausea; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 12342531 ↗
• InjuryAug 16, 2021Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, HERNIA RECURRENCE, ADHESIONS, PAIN, INFLAMMATION, MESH MIGRATION, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE AND DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND MESH INTERVENTION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Adult Respiratory Distress Syndrome; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fistula; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Perforation; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12325293 ↗
• InjuryJul 2, 2021Mechanics 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OPEN DRAINING WOUND, ADHESIONS, NECROSIS, ABSCESS, INFECTION, SEROMA-LIKE FLUID, AND PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Erythema; Fever; Fluid Discharge; Hyperresponsive to stimuli; Impaired Healing; Inflammation; Necrosis; Pain; Peritonitis; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12112442 ↗
• InjurySep 22, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, PAIN, DISCOMFORT, INFLAMMATION, ADHESIONS, RECURRENCE, OBSTRUCTION, AND SEROSAL INJURIES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND SMALL BOWEL RESECTION.

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

  MAUDE report 10565392 ↗
• InjuryApr 17, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AFTER A HERNIA REPAIR, THE PATIENT WAS ADMITTED DUE TO RECURRENT INCISIONAL HERNIA AND PAIN. THE PATIENT WAS TAKEN FOR A LAPAROSCOPIC REPAIR AND IT WAS NOTED DURING SURGERY THAT THE MESH WAS INTACT CIRCUMFERENTIALLY WITH "A HOLE BLOWN RIGHT OUT OF THE MIDDLE" AND A SIGNIFICANT AMOUNT OF EXUDATE IN THE HERNIA SAC WITH CONCERN FOR BACTERIAL TRANSLOCATION. A PRIMARY REPAIR OF THE HERNIA WAS PERFORMED.

  Patient problems: Bacterial Infection; Hernia; No Code Available; No Information; Pain; Unspecified Infection

  MAUDE report 8525083 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SMALL BOWEL OBSTRUCTION, ABDOMINAL PAIN, DEFECT IN MESH, FREE FLUID, INFLAMMATORY CHANGES IN SOME MURKY FLUID, ADHESIONS, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RECURRENCE REPAIR AND EXCISION OF MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Ascites; Failure of Implant; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Tissue Injury

  MAUDE report 8484897 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 3 DAYS AFTER LAPAROSCOPIC RECURRENT VENTRAL HERNIA REPAIR, THE PATIENT WAS IN AN IMMENSE AMOUNT OF PAIN. THE PATIENT'S FAMILY CALLED THE SURGEON AND INFORMED HIM THAT THE PATIENT HAD NOT TAKEN ANY OF THE MEDICATION POST OPERATIVELY BUT WAS IN A GREAT DEAL OF PAIN. THE SURGEON TOLD THE PATIENT TO TAKE THE MEDICATION AND WHEN THE PATIENT'S STATUS WAS CHECKED, THE PATIENT WAS DOING BETTER BUT STILL IN PAIN. THE PATIENT CAME TO THE HOSPITAL AND DID A COMPUTED TOMOGRAPHY (CT) SCAN. FLUID IN HIS STOMACH WAS SEEN AND THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROSCOPIC PROCEDURE. THEY STARTED THE PROCEDURE LAPAROSCOPIC AND NOTICED THE AREA TO BE EXTREMELY RED AND THE MESH HAD MILD ADHESIONS. AT THE TIME HIS WHITE BLOOD CELL COUNT WAS ONLY 11 AND SO THEY DID NOT BELIEVE HE HAD AN INFECTION. THEY ALSO NOTICED A FLUID IN THE ABDOMEN. SEROMA AND "FLUID FOUL SMELLING DISCHARGE THROUGH DRAINS" WERE ALSO NOTED. THE MESH WAS EXPLANTED AND THE SURGEON WAS CONCERNED THAT THE PATIENT MIGHT HAVE AN ALLERGY TO PORCINE, GLYCEROL OR POLYESTER. ONLY KNOWN ALLERGIES OF THE PATIENT WERE THAT HE WAS ALLERGIC TO ANTIHISTAMINES. PATIENT WAS MORBIDLY OBE

  Patient problems: Adhesion(s); Fluid Discharge; No Code Available; Pain; Reaction; Tissue Damage

  MAUDE report 8124051 ↗