DextileRecalls & reported problems across all models

We found 6 models of Dextile by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2020 and Sep 28, 2026 — classified as 40 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Dextile problems

Dextile models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dextile DXT1510AR

  Mesh, surgical, polymeric
  29 reports
• Dextile DXT1510AL

  Mesh, surgical, polymeric
  14 reports
• Dextile DXT1309AR

  Mesh, surgical, polymeric
  10 reports
• Dextile DXT1309AL

  Mesh, surgical, polymeric
  6 reports
• Dextile DXT1612AR

  Mesh, surgical, polymeric
  4 reports
• Dextile DXT1612AL

  Mesh, surgical, polymeric
  3 reports

Recent Dextile adverse event reports

The 15 most recent reports across all models, 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 50925397 ↗
• 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 25414043 ↗
• 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 19, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, PAIN, ADHESIONS, INFECTION, BACTERIAL INFECTION, DISABILITY, DIARRHEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, MESH REMOVAL, MEDICATION.

  Patient problems: Adhesion(s); Bacterial Infection; Diarrhea; Distress; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25219337 ↗
• 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 25061110 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN OPERATION FOR AN INGUINAL HERNIA WITH THE INSTALLATION OF THE RIGHT MESH, THE PATIENT EXPERIENCED PAIN DESCRIBED AS BURNING, PINCHING AND HEAVINESS IN THE TESTICLES, WHICH BORDERED ON DISCOMFORT. THE PATIENT WAS EXHAUSTED BY THE CONTINUITY OF PAIN AND REPORTED RESTRICTION IN CARRYING LOADS AT WORK, INITIALLY LIMITED TO 10 KG AND THEN REDUCED TO 6 KG DUE TO PAIN. THE PAIN OCCURRED AT ANY TIME OF THE DAY OR NIGHT, REGARDLESS OF EFFORT OR POSITION.

  Patient problems: Discomfort; Pain

  MAUDE report 24635803 ↗
• InjuryJan 27, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGICAL TREATMENT FOR A RIGHT INGUINAL HERNIA, THE PATIENT EXPERIENCED PERSISTENT GROIN PAIN, ABDOMINAL PAIN, PAIN RADIATING TO THE RIGHT TESTICLE AND RIGHT LUMBAR FOSSA, SIGNIFICANT CONSTIPATION TENDENCY, TINGLING AT THE LEVEL OF THE PROSTHESIS, A FEELING OF SUPPORT AT THE PROSTHESIS SITE, THROBBING PAIN WITH A PAINFUL BACKGROUND, INCREASED FREQUENCYOF URINATION (10¿12 TIMES/DAY FOR 5 DAYS), AND TRACES OF BLOOD ON A URINE STRIP TEST. IMAGING AND CLINICAL SUSPICION INDICATED POSSIBLE MIGRATION OF THE PROSTHESIS, WITH COMPUTED TOMOGRAPHY REVEALING INFILTRATION OF FAT INTO THE RIGHT ILIAC FOSSA AT THE PROXIMAL ORIFICE OF THE RIGHT INGUINAL CANAL. THE PATIENT REPORTED DISABLING PAIN AS AN IMPACT. PRE-EXISTING CONDITIONS INCLUDED FIBROMYALGIA, IRRITABLE BOWEL SYNDROME, VARICOCELE IN THE LEFT TESTICLE, CRYPTORCHIDISM IN CHILDHOOD, AND A HISTORY OF LIGAMENTOPLASTY OF THE LEFT ANKLE. IMAGING ALSO IDENTIFIED A 22 MM HEPATIC CYST. A MEDICATION PRESCRIBE D TAKE.

  Patient problems: Infiltration into Tissue; Pain; Unintended Radiation Exposure

  MAUDE report 24196442 ↗

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