Dextile DXT1309ARRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521726499), received between Aug 18, 2021 and May 1, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED SEVERE AND PERSISTENT PAIN OCCURRING CONTINUOUSLY DURING THE DAY AND NIGHT, RESULTING IN SIGNIFICANT FUNCTIONAL IMPAIRMENT. THE PAIN LED TO A SUBSTANTIAL DECREASE IN QUALITY OF LIFE AND INABILITY TO PERFORM NORMAL DAILY ACTIVITIES, INCLUDING WALKING, DRIVING, DRESSING, PERSONAL HYGIENE, AND INDEPENDENTLY GETTING OUT OF BED. THE PATIENT WAS UNABLE TO WORK AND REPORTED DIFFICULTY CARING FOR A DEPENDENT CHILD DUE TO THE CONDITION. THE PATIENT REPORTED ASSOCIATED SYMPTOMS INCLUDING SIGNIFICANT ABDOMINAL SWELLING AND EPISODES OF ANAL BLEEDING. FURTHER DIAGNOSTIC INVESTIGATIONS, INCLUDING A COLONOSCOPY AND EXPLORATORY FIBROSCOPY, WERE PLANNED; HOWEVER, THE PATIENT REPORTED PHYSICAL EXHAUSTION AND PSYCHOLOGICAL DISTRESS, RESULTING IN POSTPONEMENT OF ADDITIONAL INVASIVE PROCEDURES. DESPITE ONGOING MEDICAL MANAGEMENT, INCLUDING PHYSIOTHERAPY, TOPICAL ANALGESIC TREATMENT, OPIOID PAIN MEDICATION, AND ANTIDEPRESSANT THERAPY, THE PATIENT REPORTED NO IMPROVEMENT. THE CONDITION WAS DESCRIBED AS PROGRESSIVELY WORSENING. ADDITIONAL ONGOING SYMPTOMS INCLUDED CHRONIC FATIGUE, RECURRENT ILLNESS, ABDOMINAL DISTENSION, NAUSEA, HEADACHES, BACK PAIN, AND

  Patient problems: Abdominal Distention; Back pain; Fatigue; Headache; Hemorrhage/Blood Loss/Bleeding; Nausea; Unintended Radiation Exposure

  MAUDE report 25054832 ↗
• MalfunctionJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT INGUINAL HERNIA OPERATION VIA LAPAROSCOPY WITH PLACEMENT OF A MESH, PERSISTENT PAIN LASTING MORE THAN THREE MONTHS WAS EXPERIENCED. THE PAIN BECAME INCREASINGLY BOTHERSOME AND DEBILITATING. CONCERNS WERE RAISED ABOUT POSSIBLE BODY REJECTION OF THE PROSTHESIS AND POTENTIAL NERVE DAMAGE CAUSED BY THE OPERATION, AS WELL AS UNCERTAINTY REGARDING THE PROGRESSION OF THE SITUATION. THE PATIENT REQUESTED AN ULTRASOUND AND A COMPUTED TOMOGRAPHY SCAN, BUT THESE WERE NOT SUGGESTED BY THE SURGEON. PAIN MANAGEMENT MEDICATIONS WERE PRESCRIBED AS PART OF THE PATIENT¿S TREATMENT.

  Patient problems: Pain

  MAUDE report 24123176 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, DISABILITY, SCARRING.

  Patient problems: Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22896557 ↗
• 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 22194990 ↗
• 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 20233000 ↗
• 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 20225802 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO TOTALLY EXTRAPERITONEAL INGUINAL HERNIA REPAIR, THE PATIENT HAD A SWOLLEN GROIN ON THE SAME SIDE OF THE PROCEDURE (RIGHT). THE PATIENT HAD INGUINAL HERNIA RECURRENCE.

  Patient problems: Hernia; Insufficient Information; Swelling/ Edema

  MAUDE report 14145723 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO TOTALLY EXTRAPERITONEAL INGUINAL HERNIA REPAIR, THE PATIENT HAD A SWOLLEN GROIN ON THE SAME SIDE OF THE PROCEDURE (RIGHT). THE PATIENT HAD INGUINAL HERNIA RECURRENCE.

  Patient problems: Hernia; Insufficient Information; Swelling/ Edema

  MAUDE report 14145445 ↗
• 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 12416338 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT, THE PATIENT HAD A HEMATOMA LEFT GROIN WITHOUT PAIN, FOLLOWING A TOTALLY EXTRAPERITONEAL REPAIR. IT WAS STATED THAT THE HEMATOMA WAS ALREADY GETTING SMALLER.

  Patient problems: Hematoma

  MAUDE report 12335216 ↗