SymbotexRecalls & reported problems across all models

We found 31 models of Symbotex by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 1,979 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2017 and Sep 29, 2026 — classified as 20 deaths, 1,905 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (960 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 Symbotex problems

Symbotex models

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

• Symbotex SYM12

  Mesh, surgical, polymeric
  3 deaths383 reports
• Symbotex SYM9

  Mesh, surgical, polymeric
  2 deaths354 reports
• Symbotex SYM1510

  Mesh, surgical, polymeric
  2 deaths261 reports
• Symbotex SYM2015

  Mesh, surgical, polymeric
  2 deaths242 reports
• Symbotex SYM15

  Mesh, surgical, polymeric
  3 deaths196 reports
• Symbotex SYM2520

  Mesh, surgical, polymeric
  130 reports
• Symbotex SYM3020

  Mesh, surgical, polymeric
  1 death50 reports
• Symbotex SYM1510OS

  Mesh, surgical, polymeric
  1 death48 reports
• Symbotex SYM1710E

  Mesh, surgical, polymeric
  1 death46 reports
• Symbotex SYM2515E

  Mesh, surgical, polymeric
  1 death37 reports
• Symbotex SYM2015OS

  Mesh, surgical, polymeric
  1 death36 reports
• Symbotex SYM2012E

  Mesh, surgical, polymeric
  29 reports
• Symbotex SYM3728

  Mesh, surgical, polymeric
  1 death26 reports
• Symbotex SYM2520OS

  Mesh, surgical, polymeric
  20 reports
• Symbotex SYM8OS

  Mesh, surgical, polymeric
  17 reports
• Symbotex SYM20

  Mesh, Surgical, Polymeric
  15 reports
• Symbotex SYM2520F

  Mesh, surgical, polymeric
  13 reports
• Symbotex SYM2015F

  Mesh, surgical, polymeric
  11 reports
• Symbotex SYM3020OS

  Mesh, surgical, polymeric
  10 reports
• Symbotex SYM15F

  Mesh, surgical, polymeric
  8 reports
• Symbotex SYM12F

  Mesh, Surgical, Polymeric
  7 reports
• Symbotex SYM1510F

  Mesh, surgical, polymeric
  7 reports
• Symbotex SYM3420E

  Mesh, surgical, polymeric
  1 death7 reports
• Symbotex SYM3020F

  Mesh, Surgical, Polymeric
  6 reports
• Symbotex SYM9F

  Mesh, surgical, polymeric
  6 reports
• Symbotex SYM4232

  Mesh, surgical, polymeric
  1 death5 reports
• Symbotex SYM2012EF

  Mesh, surgical, polymeric
  4 reports
• Symbotex SYM1710EF

  Mesh, surgical, polymeric
  2 reports
• Symbotex SYM3420EF

  Mesh, surgical, polymeric
  1 report
• Symbotex SYM4024E

  Mesh, surgical, polymeric
  1 report
• Symbotex SYM4024EF

  Mesh, surgical, polymeric
  1 report

Recent Symbotex adverse event reports

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

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 50938585 ↗
• InjurySep 24, 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 implant, the patient experienced emotional distress, hernia recurrence, adhesions, pain, & suffering. Post-operative patient treatment included revision surgery, lysis of adhesions, & hernia repair.

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

  MAUDE report 50886146 ↗
• InjurySep 22, 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 adhesions, recurrence, pain and suffering. Post-operative patient treatment included removal of mesh and hernia repair with new mesh.

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

  MAUDE report 50858883 ↗
• 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 the implant, the patient experienced pain, infection, hernia recurrence, inflammation, adhesions, perforation, <(>&<)> erosion. Post-operative patient treatment included lysis of adhesions, mesh removal, small bowel resection, anastomosis, hernia repair with mesh, <(>&<)> use of JP drain.

  Patient problems: Adhesion(s); Erosion; Hernia; Inflammation; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 50082666 ↗
• InjuryJul 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 an incisional hernia. It was reported that after implant, the patient experienced pain, recurrence, adhesions, obstruction, scar tissue and difficulty having bowel movements. Post-operative patient treatment included medication, hernia repair with new mesh, lysis of adhesions and hernia repair.

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

  MAUDE report 50059929 ↗
• 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 a laparoscopic therapeutic treatment of a umbilical hernia. It was reported that after implant, the patient experienced pain, hernia recurrence, adhesions, seroma, swelling, difficulty going to restroom (may not be able to go for up to a week), scarring, mental instability based on looks/appearances. Post-operative patient treatment included medication.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Emotional Changes; Hernia; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 50008719 ↗
• InjuryJun 11, 2026Migration 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 AN INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISCOMFORT, BLOATING, ADHESIONS, MESH ENCAPSULATION, RECURRENCE, PAIN, SUFFERING, MESH MIGRATION AND BULGE IN ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Discomfort; Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25473557 ↗
• InjuryJun 2, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, HAD A HARD TIME WITH BOWEL MOVEMENTS, DEFECTIVE MESH, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, OPEN BILATERAL RECTUS MYOFASCIAL ADVANCEMENT FLAPS, OPEN BILATERAL TRANSVERSUS ABDOMINIS MYOFASCIAL ADVANCEMENT FLAPS, RESECTION OF SKIN AND TISSUE, LYSIS OF ADHESIONS AND MESH REVISION.

  Patient problems: Adhesion(s); Distress; Hernia; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 25364963 ↗
• InjuryJun 2, 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 25364562 ↗
• InjuryJun 1, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, NERVE DAMAGE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH, HOSPITALIZATION.

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

  MAUDE report 25349889 ↗
• InjuryMay 29, 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25333546 ↗
• InjuryMay 29, 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25332751 ↗
• InjuryMay 26, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN AND SUFFERING.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25281114 ↗
• DeathMay 26, 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, SUFFERING, BULGE OF HERNIA IN ABDOMEN, EMOTIONAL DISTRESS, RECURRENCE, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND HERNIA REPAIR WITH MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

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

  MAUDE report 25280890 ↗
• DeathMay 26, 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 & PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, INFECTION, ABSCESS, FISTULA, PAIN, SUFFERING, MESH NOT INCORPORATED AND FLOATING IN PURULENCE, CHRONIC OPEN WOUND, HERNIA RECURRENCE, & DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAP, REMOVAL OF INFECTED MESH, EXCISION DEBRIDEMENT OF SUBCUTANEOUS TISSUES, BOWEL RESECTION, WOUND CARE, HOSPITALIZATION, & ADDITIONAL SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Abscess; Distress; Fistula; Hernia; Impaired Healing; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25279282 ↗

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