Symbotex SYM4232Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521190603), received between Jun 11, 2019 and Aug 30, 2023 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, REVISION OF ABDOMINAL WALL FLAP.

  Patient problems: Abdominal Pain; Distress; Emotional Changes; Hernia; Pain; Scar Tissue; Seroma; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 17654717 ↗
• InjuryDec 12, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 NIGHT CRAMPS, PULLING SENSATION, LIMITED MOBILITY, HAS TO SLEEP IN HOSPITAL BED DUE TO PAIN, RECURRENCE, ADHESIONS, SEROMA, ABSCESS, INFECTION, RECURRENT FEVER, ABDOMINAL PAIN, FAILED MESH, MENTAL ANGUISH, SCARRING, DISFIGUREMENT, DEFECTIVE MESH, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOOSE MESH, INFECTION, UNINCORPORATED MESH, AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, INCISION AND DRAINAGE OF WOUND, WOUND DEBRIDEMENT, PLACEMENT OF WOUND VAC, REVISION SURGERY, AND PARTIAL EXPLANT OF MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Bruise/Contusion; Constipation; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Diarrhea; Discomfort; Distress; Electrolyte Imbalance; Emotional Changes; Erythema; Fever; Hernia; Impaired Healing; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12981859 ↗
• InjuryNov 16, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 AN INCISIONAL ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, PAIN, DISCOMFORT, FOREIGN BODY REACTION, INFLAMMATION, SCARRING, ADHESIONS, WADDED UP MESH, ABSCESS, FISTULA, INFECTION, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, REVISION SURGERY, AND BOWEL RESECTION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Chills; Dehydration; Depression; Discomfort; Dyspnea; Emotional Changes; Fever; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Nausea; Pain; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 10846437 ↗
• InjuryOct 2, 2019Material Perforation; Adverse Event Without Identified Device or Use Problem; Material Perforation; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC LAPAROSCOPIC TREATMENT OF MULTIPLE VENTRAL INCISIONAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, FEVER, CHILLS, CHEST PAIN, COLITIS, SEPSIS, ATRIAL FIBRILLATION, TENDERNESS, ERYTHEMA, FASCIA OF POOR QUALITY,COLONIC PERFORATION MESH LYING IN A LARGE AMOUNT OF LIQUID STOOL, ADHESIONS, MILD HYPOTENSION POSTOPERATIVELY, NECROSIS LARGE AMOUNT OF SANGUINEOUS DRAINAGE, SIGNIFICANT DRAINAGE FECULENT IN NATURE, WOUND DEHISCENCE, COLOCUTANEOUS FISTULA, AND CONSTIPATION. POSTOPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS, MESH EXTIRPATION, SEGMENTAL COLOSTOMY WITH END COLOSTOMY, AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Ascites; Atrial Fibrillation; Bowel Perforation; Chest Pain; Chills; Constipation; Discharge; Discomfort; Erythema; Fever; Fibrosis; Fistula; Inflammation; Injury; Ischemia; Low Blood Pressure/ Hypotension; Necrosis; No Code Available; Perforation; Purulent Discharge; Sepsis; Unspecified Infection; Wound Dehiscence

  MAUDE report 9147941 ↗
• DeathJun 11, 2019Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; 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 RECURRENT INCISIONAL HERNIA WITH INCARCERATED BOWEL. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, HERNIA RECURRENCE, BOWEL DISRUPTION, ABDOMINAL WALL SEROMA, FISTULA, OBSTRUCTION, EXPOSED MESH, PURULENT DISCHARGE WITH FOUL ODOR, OPEN ABDOMINAL WOUND, HEMATEMESIS, ABDOMINAL PAIN, NAUSEA, VOMITING, ISCHEMIA, FASCITIS, AND INFECTIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, ADDITIONAL IMPLANT FOR RECURRENCE REPAIRS, INCISION AND DRAINAGE OF SEROMA, DEBRIDEMENT, PLACEMENT OF WOUND VAC, MESH REMOVAL, ABDOMINAL WOUND SKIN GRAFT, EXPLORATORY LAPAROTOMY, EXTENSIVE ADHESIOLYSIS, SMALL BOWEL RESECTION WITH ANASTAMOSIS AND ABDOMINAL WASH OUT WITH 3 LITERS OF SALINE. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. THE PATIENT EXPIRED DUE TO CARDIO RESPIRATORY FAILURE & ACUTE RENAL DISEASE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Abdominal Pain; Adhesion(s); Erosion; Fistula; Hernia; Impaired Healing; Injury; Ischemia; Nausea; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Renal Disease, End Stage; Respiratory Failure; Seroma; Unspecified Infection; Vomiting

  MAUDE report 8689729 ↗