Symbotex SYM3420ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521190542), received between Jan 25, 2018 and Nov 3, 2023 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, SINUS TRACT, INFECTION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, EXCISION OF SINUS TRACT.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Impaired Healing; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18069118 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ELEVATED WBC, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, SEROMA, ABDOMINAL PAIN, ABDOMINAL FLUID COLLECTION, NECROSIS, FEVER, ODIFEROUS GRAYISH BROWN PUS, AND MRSA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION OF SKIN FLAP, USE OF DRAIN, CENTRAL PORTION OF LOWER TRANSVERSE INCISION RESECTED, WOUND SUCTIONED AND IRRIGATED, HOSPITAL ADMISSION, AND RESECTION OF FAT NECROSIS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Fever; Fluid Discharge; Hernia; Inflammation; Necrosis; Obstruction/Occlusion; Pain; Pleural Effusion; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17942082 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, VERY LARGE DIASTASIS, SEROMA, SKIN FLAP FAILURE WITH WOUND VAC PLACEMENT, SMALL BOWEL OBSTRUCTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC PLACEMENT.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 12320608 ↗
• InjuryMar 7, 2019Migration 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 MULTIPLE VENTRAL I INCISIONAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FLAP NECROSIS, INFECTION, PAIN, RECURRENCE, BALLED UP MESH AND FAT NECROSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REVISION OF FLAP FOLLOWING ABDOMINAL WALL RECONSTRUCTION, EXCISION OF NECROTIC TISSUE, FAT NECROSIS REMOVED AND ONE AREA OF REDUNDANT MESH WAS EXCISED.

  Patient problems: Adhesion(s); Emotional Changes; Fluid Discharge; Hernia; Inflammation; Injury; Necrosis; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8400335 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, INCARCERATED ORGANS, SMALL BOWEL OBSTRUCTION AND RECURRENCE. AFTER TREATMENT, THE PATIENT EXPERIENCED REVISION SURGERY.

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

  MAUDE report 7865032 ↗
• InjuryJul 20, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Migration 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 A HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED SURGICAL REVISION, PAIN, RECURRENCE. AFTER TREATMENT, THE PATIENT EXPERIENCED REVISION SURGERY.

  Patient problems: Adhesion(s); Cyst(s); Hernia; Injury; No Code Available; Pain

  MAUDE report 7708234 ↗
• DeathJan 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, EXTENSIVE ADHESIOLYSIS, REMOVAL OF OLD MESH AND REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH. HIS ORIGINAL SURGERY WAS 11 MONTHS AGO. THE PATIENT EXPERIENCED PAIN, ADHESIONS, AND HERNIA RECURRENCE.

  Patient problems: Adhesion(s); Fistula; Hernia; Injury; No Code Available; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection

  MAUDE report 7219999 ↗