Dextile DXT1612ARRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521726536), received between Dec 11, 2020 and Apr 16, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 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 inguinal hernia. It was reported that after implant, the patient experienced recurrence, pain, suffering, seroma, swollen testicle, discomfort, emotional distress and death. Post-operative patient treatment included revision surgery and mesh revision. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.

  Patient problems: Discomfort; Distress; Hernia; Pain; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 24905006 ↗
• MalfunctionApr 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR PROCEDURE, WHILE IMPLANTING THE MESH, THE MESH DID NOT ALIGN PROPERLY WITH THE ANATOMY OF THE PATIENT BECAUSE OF THE ANATOMICAL PROPERTIES OF THE MESH. THIS CAUSED THE INFERIOR PORTION OF THE MESH TO NOT LAY PROPERLY. THE SURGEON ALSO STATED THAT THE MESH DID NOT GIVE ENOUGH MEDICAL COVERAGE FOR THE SURGEON TO FEEL COMFORTABLE LEAVING THE MESH IN PLACE. THE SURGEON DECIDED TO USE A DIFFERENT MESH TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215606 ↗
• InjuryNov 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A ROBOTIC INGUINAL HERNIA REPAIR, THE PATIENT WAS HAVING PAIN AND WAS HAVING TROUBLE WALKING DUE TO THE PAIN. THE PATIENT WAS EXAMINED BY THE SURGEON UNDER ROBOTIC LAPAROSCOPY AND IT WAS CONFIRMED THAT AN INGUINAL HERNIA REOCCURRENCE WAS PRESENT IN THE PATIENT'S RIGHT INGUINAL SPACE THE MESH WAS VISIBLY CURLED ON THE LATERAL EDGE. THE HERNIA WAS REDUCED AND THE MESH DISSECTED BUT WAS UNABLE TO BE EXPLANTED.

  Patient problems: Hernia

  MAUDE report 12849955 ↗
• MalfunctionDec 11, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR PROCEDURE, THE SURGEON WAS UNABLE TO INSERT THE MESH ON THE TROCAR FOR IT WAS DAMAGED. ANOTHER MESH WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991599 ↗