Dextile DXT1510ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521726529), received between Aug 18, 2021 and Sep 28, 2026 — classified as 6 injuries, 8 malfunctions.

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

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50923974 ↗
• MalfunctionJun 5, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, APPROXIMATELY TWO WEEKS AFTER THE OPERATION OF BILATERAL LAPAROSCOPIC INGUINAL HERNIA (TEPP) CURE WITH RIGHT ILIAC DISSECTION, THERE WAS AN APPEARANCE OF INTENSE BURNS IN THE THIGHS, A REAPPEARANCE OF THE SAME PAINS (SOMETIMES STRONGER) IN THE HERNIAS BEFORE THE OPERATION, AND BIG PAINS IN THE LOWER ABDOMEN ON BOTH SIDES. IT WAS ALSO NOTED THAT THE PATIENT REPORTED THE PRESENCE OF LEFT INGUINAL PAIN ON ADMISSION WITH A LEFT HERNIA TIP ON A CLINICAL EXAMINATION. MOREOVER, SINCE THE ONSET OF THE PAIN, THE BURNS IN THE THIGHS HAVE DECREASED BUT HAVE NOT DISAPPEARED. ALL THE OTHER PAINS WERE STILL PRESENT AND HANDICAPPED THE PATIENT IN MY EVERYDAY LIFE.

  Patient problems: Burning Sensation; Pain

  MAUDE report 25414031 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, PAIN, SUFFERING, EMOTIONAL DISTRESS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND HERNIA REPAIR WITH MESH.

  Patient problems: Abscess; Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25204421 ↗
• MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MESHES WERE IMPLANTED FOR TREATMENT OF A BILATERAL LAPAROSCOPIC INGUINAL HERNIA. APPROXIMATELY 1 MONTH AFTER IMPLANTATION, THE PATIENT EXPERIENCED GROIN PAIN, LEG PAIN WITH CRAMPS, AND BACK PAIN. THE PATIENT ALSO REPORTED INTENSE, CHRONIC TIREDNESS CAUSING DISCOMFORT. THE SYMPTOMS REPORTEDLY PROGRESSED FROM THE LEGS TO THE ARMS, WITH ARM SYMPTOMS REPORTED LATER. ANOTHER DEVICE USED WAS FROM COMPETITOR'S SYNTHETIC ADHESIVE.

  Patient problems: Back pain; Discomfort; Limb Pain; Pain

  MAUDE report 25060493 ↗
• InjuryApr 29, 2026Adverse 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 A THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, PAIN, SEXUAL DYSFUNCTION, NUMBNESS, CONSTIPATION, PROBLEMS/DIFFICULTY URINATING, NERVE DAMAGE, NERVE ENTRAPMENT, DEVICE DEFECTIVE, PRESSURE IN GROIN, DIGESTIVE COMPLICATIONS, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Distress; Nerve Damage; Numbness; Pain; Sexual Dysfunction; Unspecified Gastrointestinal Problem; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury

  MAUDE report 25035415 ↗
• MalfunctionJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN OPERATION IN (B)(6) 2021 FOR THE INSTALLATION OF THE LEFT AND RIGHT MESH, POLYPROPYLENE PROSTHESES FOR BILATERAL INGUINAL HERNIAS AT THE GROIN LEVEL, PERSISTENT PAIN AT THE IMPLANT SITE OCCURRED DAILY AND HAS CONTINUED SINCE 2021. THE PAIN WAS DESCRIBED AS MORALLY DISTRESSING AND SOMETIMES MORE INTENSE, REQUIRING STRETCHING OR CHANGES IN POSITION FOR TEMPORARY RELIEF. THE PAIN ALSO HANDICAPPED THE PATIENT'S SEX LIFE, WITH INTENSE PAIN OCCURRING AFTER SEXUAL ACTIVITY, AND IMPACTED PARTICIPATION IN SPORTS, WITH INCREASED PAIN DURING CERTAIN MOVEMENTS. MEDICATION PRESCRIBED FOR NERVE PAIN DID NOT DECREASE THE PAIN, EVEN AT INCREASED DOSES. REHABILITATION WITH A PHYSIOTHERAPIST REDUCED THE PAIN, BUT IT RETURNED QUICKLY IF EXERCISES WERE STOPPED.

  Patient problems: Pain; Sexual Dysfunction

  MAUDE report 24172239 ↗
• InjuryJan 20, 2026Adverse 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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 24122240 ↗
• MalfunctionSep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A TOTALLY EXTRAPERITONEAL (TEP) HERNIA REPAIR USING MESH FOR AN INGUINAL HERNIA EXPERIENCED A HERNIA RECURRENCE DURING THE POST-OPERATIVE PERIOD. THE PROCEDURE WAS PERFORMED LAPAROSCOPICALLY, AND THE MESH WAS NOT CUT PRIOR TO IMPLANTATION, WAS NOT IMPLANTED IN A CONTAMINATED FIELD, AND APPEARED NORMAL AT THE TIME OF USE. THE WOUND WAS CLOSED WITH SUTURES, AND NO FIXATION SYSTEM WAS USED. THE RECURRENCE WAS IDENTIFIED DURING A PATIENT-PHYSICIAN POST-OPERATIVE FOLLOW-UP. THE RECURRENCE RESULTED IN A TEMPORARY INJURY, BUT NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Hernia

  MAUDE report 23160562 ↗
• MalfunctionFeb 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LEFT INGUINAL HERNIA, AFTER THE MESH WAS OPENED, IT WAS NOTICED THAT THE EDGES WERE FRAYED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18673052 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, POSTOPERATIVELY, OF LAPAROSCOPIC INGUINAL HERNIA, THERE WAS PAIN IN THE RIGHT GROIN AFTER HEAVY LIFTING. AN ULTRASOUND WAS PERFORMED, AND THERE WAS A RECURRENCE OF INGUINAL HERNIA AT THE RIGHT CAUDAL AREA FROM THE TOTALLY EXTRAPERITONEAL (TEP) MESH. THE PATIENT PLANNED FOR LICHTENSTEIN RIGHT. IT WAS NOTED THAT THE DEVICE WAS PROBABLE RELATED AND STUDY PROCEDURE WAS POSSIBLE RELATED.

  Patient problems: Hernia; Pain

  MAUDE report 18013758 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF A STUDY CONDUCTED BETWEEN 2019 AND 2022, A RETROSPECTIVE STUDY EVALUATED OUTCOMES IN PATIENTS WHO UNDERWENT THE STANDARDIZED TOTAL EXTRA-PERITONEAL TECHNIQUE. IN SOME PATIENTS, A SPACEMAKER DISSECTION BALLOON WAS USED TO DISSECT THE EXTRA-PERITONEAL SPACE. DEXTILE ANATOMICAL MESH (10X15) OR A COMPETITOR MESH WAS PLACED WITHOUT FIXATION TO COVER ALL POTENTIAL HERNIA DEFECTS. THERE WERE 416 PATIENTS IN THE DEXTILE GROUP AND 540 PATIENTS IN THE COMPETITOR GROUP. POSTOPERATIVE COMPLICATIONS RELATED TO THE MESH INCLUDED SEROMA, HEMATOMA, PAIN, AND HERNIA RECURRENCE. COMPLICATIONS RELATED TO SPACEMAKER INCLUDED WOUND INFECTION AND DELAYED WOUND HEALING. RECURRENCES WERE DUE TO EITHER A LIPOMA OR A TRUE RECURRENCE, REQUIRING EITHER SURGICAL REPAIR OR CONSERVATIVE TREATMENT. PAIN WAS MANAGED WITH ANALGESICS, LIDOCAINE INJECTIONS, OR PULSED RADIOFREQUENCY ABLATION. ANTIBIOTICS WERE NECESSARY FOR INFECTION, AND PROLONGED HOSPITALIZATION WAS REPORTED.

  Patient problems: Hematoma; Hernia; Pain; Seroma

  MAUDE report 17906584 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SEVEN MONTHS AFTER A LAPAROSCOPIC INGUINAL HERNIA REPAIR (TEP), DURING OFFICE VISIT, AFTER PHYSICAL EXAMINATION AND ANAMNESIS, THE SURGEON NOTICED THAT THERE WAS A GROIN HERNIA RECURRENCE LEFT. TO RESOLVE THE ISSUE, A NEW OPERATION WILL BE PLANNED AND A LICHTENSTEIN LEFT WILL BE PERFORMED. THE SITE HAS ENTERED THE EVENT AND ASSESSED AS POSSIBLE RELATEDNESS TO THE STUDY DEVICE.

  Patient problems: Hernia; Unintended Radiation Exposure

  MAUDE report 14454992 ↗
• MalfunctionNov 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PREOPERATIVE TO INGUINAL HERNIA SURGERY, WHEN PACKAGE WAS OPENED, THE MESH WAS FOUND TORN. ANOTHER MESH WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762862 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 29 DAYS POST OPERATIVE ON A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE PATIENT HAD HEMATOMA ON LEFT GROIN. IT WAS NOTICED AT THE OFFICE VISIT. PATIENT HAS NO COMPLAINTS OF IT.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335211 ↗