Alyte Y-Mesh GraftRecalls & reported problems across all models

We found 2 models of Alyte Y-Mesh Graft by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2013 and Jul 17, 2026 — classified as 1 death, 154 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (5 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 Alyte Y-Mesh Graft problems

Alyte Y-Mesh Graft models

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

• Alyte™ Y-Mesh Graft Y100

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  1 death84 reports
• Alyte™ Y-Mesh Graft Y500

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  76 reports

Recent Alyte Y-Mesh Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL, EROSION OF IMPLANTED VAGINAL MESH AND PROSTHETIC MATERIALS, OVERACTIVE BLADDER, MIXED STRESS AND URGE URINARY INCONTINENCE, URINARY TRACT INFECTION, DETRUSOR DYSFUNCTION. PER MEDICAL RECORDS WERE RECEIVED ON 23JUN2026, THE PATIENT HAS EXPERIENCED SEVERE BOWEL ADHESIONS TO THE VAGINAL CUFF, SEVERE BOWEL ADHESIONS TO THE PELVIC SIDEWALL, SEVERE BOWEL ADHESIONS TO THE PELVIS POSTERIOR CUL-DE-SAC, URINARY INCONTINENCE, NARROWED VAGINAL INTROITUS, VAGINAL MESH EROSION AT THE APEX, BLEEDING, VAGINAL PROLAPSE, HEMORRHAGE, EDEMA, ANEMIA, OVERACTIVE BLADDER, URINARY RETENTION, E COLI URINARY TRACT INFECTION, STRESS, LOWER BACK PAIN, DYSURIA, FREQUENCY, FEVER, VAGINAL WOUND, URETHRAL WOUND, OVERACTIVE GENITOURINARY, PAIN, INCOMPLETE EMPTYING OF BLADDER, DETRUSOR DYSFUNCTION, URGENCY, ANXIETY, MESH EXPOSURE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Adhesion(s); Anemia; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Dysuria; Erosion; Fever; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Pain; Prolapse; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 25856899 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED CONTINUOUS FOUL SMELLING AND FECULENT VAGINAL DISCHARGE, RECURRENT E. COLI URINARY TRACT INFECTIONS, PASSAGE OF GAS THROUGH VAGINA, YELLOW OR BROWN DISCHARGE WITH BLOOD MIXED, FOUL SMELLING DISCHARGE, RECTOVAGINAL FISTULA, MESH EROSION, COMPLICATED AND PROLONGED EXTENSIVE SURGERY, PAIN, MILD ILEUS, CHRONIC PAIN, SEXUAL DYSFUNCTION, MULTIPLE REVISION SURGERIES, COLOVAGINAL FISTULA, DENSE ADHESIONS OF THE COLON TO THE POSTERIOR VAGINA AND ADHESIONS OF THE ASCENDING AND DESCENDING COLON TO THE PELVIC SIDEWALLS, PROLONGED POST OPERATIVE COMPLICATIONS.

  Patient problems: Abnormal Vaginal Discharge; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fistula; Pain; Urinary Tract Infection

  MAUDE report 25854752 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3MM MESH EXTRUSION ON POSTERIOR WALL VAGINA. MRI PELVIS REQUESTED AND STARTING VAGINAL OESTROGEN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23476928 ↗
• InjuryOct 3, 2024Adverse 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 09-SEP-2024, THE PATIENT HAD EXPERIENCED PELVIC PAIN, DYSPAREUNIA, VAGINAL MESH EXPOSURE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 20360578 ↗
• InjuryAug 20, 2024Adverse 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 24-JUL-2024, THE PATIENT HAD EXPERIENCED VAGINAL PAIN, MESH EROSION, CHRONIC INFLAMMATION, VAGINAL PROLAPSE, PERSISTENT ATRIAL FIBRILLATION, HEAT INTOLERANCE, MASS ON RIGHT SIDE OF NECK, SHORTNESS OF BREATH, FEVER AND CHILLS, INSOMNIA, DYSPHAGIA, HEMORRHOIDS, CONSTIPATION, PEDAL EDEMA, MODERATE EPISODE OF RECURRENT MAJOR DEPRESSIVE DISORDER, PERIPHERAL NEUROPATHY, POSTMENOPAUSAL SYMPTOMS, ANORECTAL SPASM, SIGMOID DIVERTICULOSIS, STRESS INCONTINENCE, SYMPTOMATIC CHOLELITHIASIS, VAGINAL ATROPHY, SPINAL STENOSIS, SPONDYLOLISTHESIS, MYOFASCIAL PAIN, BACK PAIN, ANOREXIA, NAUSEA, VOMITING, PELVIC ABSCESS, COLO-VESICAL FISTULA, ACUTE CYSTITIS, DYSURIA, BOIL OF BUTTOCK, PRURITIC RASH, BURNING SENSATION, LOWER ABDOMINAL PAIN, BOWEL LEAKAGE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abscess; Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrial Fibrillation; Burning Sensation; Chills; Constipation; Cramp(s) /Muscle Spasm(s); Depression; Diarrhea; Dysphagia/ Odynophagia; Dysuria; Erosion; Fatigue; Fever; Headache; Hematuria; Incontinence; Inflammation; Muscle Weakness/Atrophy; Nausea; Neuropathy; Pain; Prolapse; Rash; Stenosis; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Tract Infection; Vomiting

  MAUDE report 20008746 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE LITIGATION DOES NOT SPECIFICALLY STATE WHICH PRODUCT WAS USED ON THE PATIENT THEREFORE AN UNKNOWN COMPLAINT IS BEING ENTERED. AS PER MEDICAL RECORD REVIEW OF DOCUMENTS RECEIVED ON (B)(6) 2024, THE PATIENT HAD EXPERIENCED INCONTINENCE, PROLAPSE, RECTOCELE, INTERNAL COMPLETE RECTAL PROLAPSE WITH INTUSSUSCEPTION OF RECTOSIGMOID, EROSION OF IMPLANTED VAGINAL AND URETHRAL MESH, DYSPAREUNIA, TIGHTNESS, PRESSURE, NAUSEA, VOMITING, PAIN, URINARY OBSTRUCTION, ABNORMAL HEART RHYTHM, ATRIAL FIBRILLATION, SHORTNESS OF BREATH, OSTEOARTHRITIS, INFECTION, PELVIC PAIN, ABDOMINAL PAIN, CONSTIPATION, BLADDER IRRITATION, BLADDER PAIN, FACE REDNESS, BURNING, RAPID HEART RATE DUE TO BARIUM ALLERGY, ANORECTAL PAIN AND BLEEDING, ASYMPTOMATIC INTERNAL HEMORRHOIDS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Atrial Fibrillation; Constipation; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Incontinence; Nausea; Obstruction/Occlusion; Pain; Prolapse; Skin Inflammation/ Irritation; Tachycardia; Unspecified Infection

  MAUDE report 19499667 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED CHRONIC PAINFUL INFECTIONS, PELVIC AND PERINEAL PAIN, LOWER BACK AND BILATERAL FLANK PAIN, DYSURIA, SCARRING, RECURRENT PROLAPSE, AND MESH EROSION. AS PER MEDICAL RECORD REVIEW OF DOCUMENT RECEIVED ON 03-MAY-2024, THE PATIENT EXPERIENCED CHRONIC PAINFUL INFECTIONS, PELVIC AND PERINEAL PAIN, LOWER BACK AND BILATERAL FLANK PAIN, DYSURIA, SCARRING AND MESH EROSION, CYSTOCELE, RECTOCELE, UTERINE BLEEDING, PELVIC ORGAN PROLAPSE, VAGINAL INFECTION, URINARY LEAKAGE, URGENCY, FREQUENCY, URGE INCONTINENCE, STRESS INCONTINENCE, ATROPHY, FLATUS INCONTINENCE, CHRONIC URINARY TRACT INFECTIONS, CONSTIPATION, CYSTITIS AND REQUIRED ADDITIONAL SURGICAL AND NON - SURGICAL TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Dysuria; Erosion; Flatus; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Muscle Weakness/Atrophy; Pain; Prolapse; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 19393019 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 18-NOV2024, THE PATIENT HAD EXPERIENCED UTEROVAGINAL PROLAPSE, BOWEL OBSTRUCTION, THIRD DEGREE RECTOCELE, SECOND DEGREE CYSTOCELE, EXTERNAL HEMORRHOID, RECTOVAGINAL FISTULA, VULVODYNIA, MIGRAINES, CHRONIC INTERSTITIAL CYSTITIS, ABDOMINAL PAIN, DYSURIA, DYSPAREUNIA, URINARY FREQUENCY, NOCTURIA, URINARY URGENCY, COLITIS, TRIGEMINAL NEURALGIA, YELLOWISH DISCHARGE FROM VAGINA, LEAKAGE, OSTEOARTHRITIS, SCOLIOSIS, DISCOMFORT TO THE EPIGASTRIC AREA AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Discomfort; Dyspareunia; Dysuria; Interstitial Cystitis; Micturition Urgency; Neuralgia; Obstruction/Occlusion; Pain; Prolapse; Rectovaginal Fistula; Urinary Frequency / Polyuria

  MAUDE report 19229723 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 15NOV2023 THE PATIENT HAD EXPERIENCED INCREASED ABDOMINAL PAIN POST-SURGICAL COMPLICATIONS FOLLOWING VAGINAL PROLAPSE REPAIR, ACUTE VAGINITIS, ATROPHY OF THE VAGINA, SEPTIC SHOCK, VAGINAL BLEEDING, SEVERE GENERAL PAIN, MIGRAINES, ODOROUS DARK-BROWN DISCHARGE, DEPRESSION, BACK PAIN, FREQUENT URGE TO URINATE, ABNORMAL DISCHARGE, BACTERIAL INFECTION, VISION ISSUES, SEPSIS, HEADACHE, TERRIBLE LEFT EYE GLARE, STROKE, DEVELOPS EPISODES OF TREMORS AND LIGHTHEADEDNESS, SHORTNESS OF BREATH SYNCOPE, DIZZINESS, URINARY TRACT INFECTION, TRANSIENT ISCHEMIC ATTACK TIA. CHRONIC THORACIC COMPRESSION DEFORMITIES, DYSLIPIDEMIA, OSTEOPOROSIS, TRICUSPID VALVE REGURGITATION, PALPITATIONS, CHEST PRESSURE, WHEEZES, ANEMIA, VERTIGO, ATAXIA, AGE RELATED OSTEOPOROSIS, ANEURYSM, GASTROESOPHAGEAL REFLEX DISEASE, CHRONIC BILATERAL LOW BACK PAIN, POLYURIA AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Distention; Abdominal Pain; Abnormal Vaginal Discharge; Anemia; Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Bacterial Infection; Depression; Diarrhea; Discomfort; Dizziness; Dysuria; Erosion; Fatigue; Gastrointestinal Regurgitation; Genital Bleeding; Headache; Hemorrhage/Blood Loss/Bleeding; Hernia; Micturition Urgency; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Osteopenia/ Osteoporosis; Pain; Peritonitis; Prolapse; Sepsis; Septic Shock; Shaking/Tremors; Stroke/CVA; Syncope/Fainting; Transient Ischemic Attack; Tricuspid Valve Insufficiency/ Regurgitation; Urinary Frequency / Polyuria; Urinary Tract Infection; Vertebral Fracture; Vertigo; Visual Impairment

  MAUDE report 17624121 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 16895208 ↗
• InjuryApr 17, 2023Adverse 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED,THE PATIENT HAS EXPERIENCED PAIN, RECURRENCE, ABDOMINAL DISCOMFORT, NAUSEA, ELEVATED TEMPERATURE, RIGHT LOWER QUADRANT PAIN, ADHESIONS, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 24MAR2023, THE PATIENT HAS EXPERIENCED CHRONIC PAIN, DYSPAREUNIA, SCARRING, INFECTIONS, DISABILITY, AND REQUIRED ADDITIONAL NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nausea; Scar Tissue; Unspecified Infection

  MAUDE report 16758924 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN WHILE USING ALYTE Y-MESH GRAFT. IT WAS STATED THAT THE MESH WAS TOTALLY REMOVED.

  Patient problems: Pain

  MAUDE report 16512987 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED CHRONIC PAIN IN HER BACK AND CONTINUED TO SUFFER WITH INCONTINENCE. PATIENT UNDERWENT LAPAROSCOPY SUB-TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY AND SACROCOLPOPEXY USING A WIRE MESH IMPLANT AND LAPAROSCOPY COLPUSUSPENSION ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Dysuria; Micturition Urgency; Nausea; Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 15975624 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED VAGINAL ITCHING, VAGINAL SMELL, PELVIC PAIN, VAGINAL DISCHARGE, ABDOMINAL PAIN, DIARRHEA, CONSTIPATION, URGENCY, PAIN WHEN OPENING HER BOWELS, LEG PAIN, BOWEL LEAKAGE, URINARY FREQUENCY, ANAL PAIN, ANAL ITCHING AND ANAL TENDERNESS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Micturition Urgency; Pain; Urinary Frequency / Polyuria

  MAUDE report 15923768 ↗
• InjuryAug 25, 2022Adverse 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Discomfort; Pain

  MAUDE report 15292913 ↗

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