Symbotex SYM3020FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521190528), received between Sep 15, 2017 and Nov 11, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR SURGERY, DURING MESH-BASED ABDOMINAL WALL REINFORCEMENT WITH THE SUGARBAKER METHOD, THE MESH WAS TRIMMED AND PLACED WITH THE FRONT AND BACK REVERSED. THE MISTAKE WAS NOTICED AFTER THE SURGERY, SO ANOTHER OPERATION WAS PERFORMED THE NEXT DAY, AND AN ADDITIONAL MESH FROM ANOTHER MANUFACTURER WAS PLACED.

  Patient problems: Tissue Breakdown

  MAUDE report 23519855 ↗
• InjuryAug 1, 2025Mechanics 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NAUSEA, VOMITING, HEADACHES, FORGETFULNESS, BURNING SENSATION, ITCHING SENSATION, DIZZINESS, CRAMPING, LEFT TESTICLE PAIN, STRESS, FATIGUE, DEFECTIVE MESH, FAILURE OF MESH, MASS, RECURRENCE, ALLERGIC REACTION, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, PARTIAL MESH REMOVAL, REMOVAL OF MESH, EXCISION OF MASS.

  Patient problems: Adhesion(s); Burning Sensation; Cramp(s) /Muscle Spasm(s); Distress; Dizziness; Emotional Changes; Fatigue; Headache; Hernia; Hypersensitivity/Allergic reaction; Itching Sensation; Memory Loss/Impairment; Nausea; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting

  MAUDE report 22689442 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC STOMA HERNIA REPAIR SURGERY, DURING REINFORCEMENT OF THE ILEOSTOMY SITE, THE FRONT AND BACK SIDES OF THE MESH WERE INCORRECTLY PLACED. AN ADDITIONAL MESH WAS APPLIED LAPAROSCOPICALLY THE DAY AFTER THE SURGERY.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 22621083 ↗
• InjuryFeb 23, 2022Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, TWO FIXATION THREADS WERE NOT CONNECTED TO THE MESH AND TWO WERE WRONG KNOTTED. THE PROBLEM WAS THEN SOLVED BY TACKING THE NET. THE EVENT LED TO RECURRENCE OF HERNIA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 13585140 ↗
• MalfunctionJul 9, 2020Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PLACEMENT OF MESH TO THE ABDOMINAL WALL FOR A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, THE DEVICE MISFIRED. AFTER PLACING THE FIRST FOUR TACKERS, THE MESH FELL DOWN FROM THE ABDOMINAL CAVITY. THE TACKERS PASSED THROUGH THE GAPS OF THE MESH. THE SAID MESH WAS RE-FIXED AND STILL IMPLANTED TO PATIENT WITH THE HELP OF ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10252030 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A LAPAROSCOPIC INGUINAL HERNIA REPAIR. POST-OPERATIVELY, THE VISCERAL SIDE OF THE MESH WAS SO INTERTWINED AND THE PARIETAL SIDE PRACTICALLY WITHOUT ADHESIONS AND DID NOT HOLD. THIS EVENT LED THE PATIENT TO UNDERGO SECOND SURGERY FOR INCARCERATED RECURRENCE APPROXIMATELY 6 WEEKS POST OP. PATIENT IS ALIVE.

  Patient problems: No Code Available

  MAUDE report 6868735 ↗