Dextile DXT1309ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521726505), received between Sep 2, 2021 and Apr 24, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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.

• MalfunctionApr 24, 2026Material Deformation

  IT WAS REPORTED THAT FOLLOWING AN INGUINAL HERNIA REPAIR USING THE MESH PROSTHESIS, THE PROSTHESIS RETRACTED AND BROUGHT OUT PART OF THE HERNIA. THE PATIENT EXPERIENCED DAILY PAIN WITH SEVERAL PEAKS PER DAY, INABILITY TO CARRY WEIGHT, INABILITY TO PLAY SPORTS, DIFFICULTY DRIVING A CAR WITH A CLUTCH, AND WORK INCAPACITY.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24987471 ↗
• InjuryApr 23, 2026Migration or Expulsion of Device; 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 THE IMPLANT, THE PATIENT EXPERIENCED MESH FAILED, HERNIA RECURRENCE, MESH FOLDED, MESH MIGRATION, MENTAL PAIN, PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE.

  Patient problems: Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24972744 ↗
• MalfunctionJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE INVOLVING TWO MESH. HOWEVER, ON (B)(6) 2024, THE PATIENT EXPERIENCED PAIN IN THE STOMACH AND GROIN EVERY DAY. THE PAIN FELT LIKE A SIDE STITCH SENSATION IN BOTH THE STOMACH AND GROIN, OCCURRING BOTH AFTER EXERCISE AND AT REST. DESPITE A BLOOD TEST, A CONTROL ULTRASOUND, AND A DOPPLER, NOTHING APPEARS ABNORMAL.

  Patient problems: Pain

  MAUDE report 22194861 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, APPROXIMATELY 2 YEARS FOLLOWING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL LEFT INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT HAD A SWOLLEN LEFT GROIN; THE SAME SIDE OF THE PROCEDURE. IT WAS CONCLUDED THAT THE PATIENT HAD AN INGUINAL HERNIA RECURRENCE AFTER AN ANAMNESIS AND PHYSICAL EXAMINATION WAS PERFORMED. TO RESOLVE THE ISSUE, THE PATIENT HAD TO UNDERGO A LICHTENSTEIN LEFT PROCEDURE FOUR MONTHS LATER. IT WAS NOTED THAT THE PATIENT'S SPO2 WAS 97%. THE PATIENT HAS RECOVERED.

  Patient problems: Failure of Implant; Hernia; Laceration(s); Swelling/ Edema

  MAUDE report 20231038 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL LEFT INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT HAD A SWOLLEN LEFT GROIN; THE SAME SIDE OF THE PROCEDURE. IT WAS CONCLUDED THAT THE PATIENT HAD AN INGUINAL HERNIA RECURRENCE AFTER AN ANAMNESIS AND PHYSICAL EXAMINATION WAS PERFORMED. TO RESOLVE THE ISSUE, THE PATIENT HAD TO UNDERGO A LICHTENSTEIN PROCEDURE. IT WAS NOTED THAT THE PATIENT'S OXYGEN SATURATION (SPO2) WAS 97%. THE PATIENT HAS RECOVERED.

  Patient problems: Failure of Implant; Hernia; Laceration(s); Swelling/ Edema

  MAUDE report 20225796 ↗
• InjurySep 2, 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 A LEFT AND RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, HEMATOMA, AND URINARY INCONTINENCE. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Hematoma; Hernia; Inflammation; Pain; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 12416369 ↗