Symbotex SYM2520FRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521190498), received between Jul 25, 2019 and May 12, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR, THE MESH THAT HAD BEEN HYDRATED WITH SALINE WAS TORE IN MULTIPLE SPOTS DURING MESH INSERTION THROUGH A 12 MILLIMETER TROCAR. A NEW MESH WAS OPENED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155839 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL STUDY, A RECURRENT EVENTRATION OCCURRED FOLLOWING THE CENTRAL RUPTURE OF PROSTHESIS THAT HAD BEEN INSERTED IN 2019 FOR THE TREATMENT OF A HERNIA OF THE WHITE LINE WITH DIASTASIS. IN 2024, RECURRENCE WAS OBSERVED IN THE FORM OF AN OCCLUSIVE SYNDROME, WHICH WAS MEDICALLY TREATED, AND THERE WERE MULTIPLE EMERGENCY ROOM VISITS FOR CONSTIPATION. SURGICAL REVISION WAS REQUIRED, CONSISTING OF CURE OF THE WHITE LINE BY LAPAROCONVERTED LAPAROSCOPY WITH RETRO-MUSCULAR PROSTHETIC REINFORCEMENT. THE HOLE WAS LEFT IN PLACE AND A PROSTHETIC REINFORCEMENT WAS INSTALLED.

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

  MAUDE report 24892704 ↗
• InjuryMar 2, 2025Adverse 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

  IT WAS REPORTED THAT ON (B)(6) 2023, AN ABDOMINAL INCISIONAL HERNIA REPAIR (IPOM) WAS PERFORMED. AROUND (B)(6) 2024, ABDOMINAL DISTENSION AND SUSPICION OF RECURRENCE AROSE THE PATIENT. THERE WAS A RECURRENCE DUE TO MESH BULGING AND THE MESH WAS FOUND TO BE TORN. ANOTHER ABDOMINAL INCISIONAL HERNIA REPAIR (IPOM) WAS PERFORMED ON (B)(6) 2025 WAS PERFORMED TO RESOLVE THE ISSUE. DURING THE REOPERATION, THE MESH THAT HAD A TEAR IN IT WAS EXPLANTED. ADDITIONALLY, DURING ABDOMINAL WALL INCISIONAL HERNIA REPAIR, ADHESION DELAMINATION OF THE PREVIOUS MESH RUPTURE REGION, HERNIA ORIFICE CONSTRICTION, AND MESH OVERLAP WERE PERFORMED AND FIXATED WITH A NON-ABSORBABLE METAL TACKER. THE SIZE OF THE ORIGINAL DEFECT OF THE HERNIA ORIFICE WAS 15 CM IN LENGTH AND 10 CM IN WIDTH AND THE NEW DEFECT WAS 10 CM IN LENGTH AND 8 CM IN WIDTH.

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 21501433 ↗
• InjuryJan 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER AN OPEN VENTRAL HERNIA PROCEDURE INVOLVING A MESH THAT WAS NOT CUT PRIOR TO IMPLANTATION, A HERNIA RECURRENCE OCCURRED IN THE COELIO. VISUALLY, A SMALL PORTION OF THE MESH WAS TORN. THE ISSUE WAS ADDRESSED BY PARTIALLY EXPLANTING THE DEVICE AND USING ANOTHER MESH TO RESOLVE THE PROBLEM.

  Patient problems: Hernia; Laceration(s)

  MAUDE report 21061303 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 20 DAYS POST-OPERATIVE OF AN INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) FOR A VENTRAL HERNIA, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF ACUTE ABDOMEN AFTER WHICH THE PATIENT WAS RE-OPERATED WITH REMOVAL OF THE MESH. AFTER THE DISSECTION AND REMOVAL OF THE MESH, IT WAS NOTICED THAT THE CONTACT AREA HAD A REACTION, WITH NO ANATOMIC STRUCTURES RECOGNIZING AMORPHOUS LIKE CONSISTENCY OF THE STRUCTURES, PERFORATIONS OF THE INTESTINES AND COLON. A RE-OPERATION WAS PERFORMED WITH RESECTION OF THE SMALL INTESTINES AND COLON, OPENING THE STOMAS AND LEAVING THE PATIENT WITH INSUFFICIENT LENGTH OF SMALL INTESTINE AND PARENTERAL FEEDING DEPENDENT. A PERMANENT STOMA HAD TO BE PLACED DUE TO THE ISSUE. DURING RECOVERY IN THE SECOND DAY, THE PATIENT RECEIVED 500CC OF BLOOD AND ON THE THIRD DAY 500CC AS WELL.

  Patient problems: Bowel Perforation; Foreign Body Reaction; Tissue Breakdown

  MAUDE report 19174455 ↗
• MalfunctionSep 28, 2023Unsealed Device Packaging; Material Split, Cut or Torn; Unsealed Device Packaging; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING HERNIA PROCEDURE, THE MATERIAL OF TWO MESHES WERE DAMAGED AND TAMPER-EVIDENT SEAL ON THE BOX WAS PEELED OR DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 17840255 ↗
• MalfunctionSep 28, 2023Unsealed Device Packaging; Material Split, Cut or Torn; Unsealed Device Packaging; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING HERNIA PROCEDURE, THE MATERIAL OF TWO MESHES WERE DAMAGED AND TAMPER-EVIDENT SEAL ON THE BOX WAS PEELED OR DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 17840247 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A HERNIA REPAIR PROCEDURE WHERE A MESH WAS USED, THE PATIENT HAD DEVELOPED CHRONIC PAIN. FIVE YEARS FOLLOWING THE IMPLANTATION, THE MESH, TACKS AND SUTURES WERE REMOVED VIA LAPAROSCOPIC PROCEDURE TO RESOLVE THE ISSUE.

  Patient problems: Hernia; Pain

  MAUDE report 17300500 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 17 DAYS FOLLOWING LAPAROSCOPIC VENTRAL HERNIA REPAIR, PATIENT WAS OPERATED AGAIN FOR INTESTINAL OBSTRUCTION DUE TO BAD ADHESIOLYSIS. THE SURGEON REMOVED THE MESH TO RESOLVE THE ISSUE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14056072 ↗
• MalfunctionFeb 1, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE STRING OF THE DEVICE WAS PULLED OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417593 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INTRAPERITONEAL ON LAY MESH PROCEDURE, THE MESH HAD EXPLANTED FROM THE ABDOMINAL WALL DUE TO BACTERIAL INFECTION. WOUND WAS CLOSED WITH A USE OF SUTURE.

  Patient problems: Bacterial Infection

  MAUDE report 12470286 ↗
• InjuryMar 16, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POSTOPERATIVE INCISIONAL HERNIA REPAIR OPEN PROCEDURE, THE COMPOSITE MESH HAS DIVIDED INTO TWO LAYERS WITH POLYESTER AND COLLAGEN SEPARATED. THE COLLAGEN LAYER IS ON TOP OF THE INTESTINES AND LIMITED THE MOVEMENTS OF THE BOWELS. THE MESH AND COLLAGEN LAYER HAS BEEN REMOVED DURING THE SECOND PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9835156 ↗
• MalfunctionJul 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE MESH TORN DURING APPLICATION. THE SURGEON THEN USED ANOTHER BRAND OF MESH TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829451 ↗