RestorelleRecalls & reported problems across all models

We found 8 models of Restorelle by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2019 and Jul 7, 2026 — classified as 104 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 Restorelle problems

Restorelle models

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

• Restorelle 501420

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  40 reports
• Restorelle 501520

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  25 reports
• Restorelle 501320

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  12 reports
• Restorelle 501450

  Mesh, surgical, polymeric
  9 reports
• Restorelle 501440

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  7 reports
• Restorelle 501460

  Mesh, surgical, polymeric
  7 reports
• Restorelle 501330

  Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
  5 reports
• Restorelle 501430

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

Recent Restorelle adverse event reports

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

• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD A RESTORELLE DEVICE IMPLANTED IN (B)(6) 2025. REPORTEDLY, THE PATIENT EXPERIENCED MODERATE VAGINAL DISCHARGE, SIGNIFICANT PELVIC PAIN AND ABNORMAL URINARY ANALYSIS. A CT OF THE ABDOMEN AND PELVIS SHOWED RIM-ENHANCING FLUID COLLECTION IN THE HYSTERECTOMY SURGICAL BED. (ACUTE ABSCESS). MRI PELVIS FINDINGS- COLLECTION IN THE PELVIC CUL-DE-SAC REGION WHICH MAY INVOLVE THE VAGINAL CUFF CURRENTLY MEASURING 7.6 X 1.2 X 0.8 CM, PREVIOUSLY 7.9 X 3.1 X 2.4 CM; REGIONAL ASSOCIATED INFLAMMATORY CHANGE AND ENHANCEMENT INVOLVING THE ADJACENT SMALL, LARGE BOWEL LOOPS IN URINARY BLADDER WITH RECTOSIGMOID WALL THICKENING AND ENHANCEMENT. THE PATIENT ALSO EXPERIENCED URINARY INCONTINENCE, POST-OP DRAINAGE FROM VAGINAL AREA, INCISIONAL INFECTION, LEFT GROIN AND LOWER QUADRANT PAIN AND SLIGHT VAGINAL BULGE. ON EXAM A SHORTENED VAGINAL VAULT AND SMALL CYSTOCELE ARE NOTED.

  Patient problems: Abnormal Vaginal Discharge; Abscess; Inflammation; Pain; Pelvic Pain; Prolapse; Unspecified Infection; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 25733478 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD A RESTORELLE Y IMPLANTED IN (B)(6) 2021. REPORTEDLY THE PATIENT EXPERIENCED VAGINAL BLEEDING, PASSING OF LARGE CLOTS AND WAS ADMITTED TO HOSPITAL. CT ABDOMEN/PELVIS ¿ WAS PERFORMED AND IDENTIFIED A SMALL AMOUNT OF COMPLEX FLUID IN VAGINAL VAULT LIKELY REPRESENTING BLOOD PRODUCTS, OTHERWISE NORMAL. ON EXAM ERODED AREA AT VAGINAL APEX IN WHICH MESH IS EXPOSED, AREA BLEEDS EASILY WHEN TOUCHED. OUTPATIENT EXCISION OF EXTRUDED MESH PROPOSED. NO CONFIRMATION OF EXCISION BEING PERFORMED AT THIS TIME.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Adhesion(s); Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Intermenstrual Bleeding; Pain; Pelvic Pain; Prolapse; Scar Tissue; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 24153092 ↗
• InjuryJan 20, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED PELVIC AND ABDOMINAL PAIN, LOWER BACK PAIN, EXTRUSION, PROTRUSION, URINARY ISSUES, RECURRENCE, STRESS URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL CRAMPING, NOCTURIA, SUPRAPUBIC PRESSURE, PAIN, PERMANENT DISFIGUREMENT, AND DIFFICULTY WITH DAILY ACTIVITIES WHICH ULTIMATELY REQUIRED SURGICAL INTERVENTION AND REMOVAL OF MESH ON (B)(6) 2024.

  Patient problems: Abnormal Vaginal Discharge; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Dyspareunia; Erosion; Fecal Incontinence; Inflammation; Pain; Pelvic Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 24115896 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD A RESTORELLE IMPLANTED IN (B)(6) 2024. REPORTEDLY THE PATIENT EXPERIENCED RIGHT HIP, BACK, AND BUTTOCK PAIN. IN (B)(6) 2025, PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS ADMITTED FOR INFECTION OF SACROCOLPOPEXY MESH (RESTORELLE Y) AT ATTACHMENT ANTERIOR L5-S1 WITH SECONDARY DISCITIS-OSTEOMYELITIS. PATIENT UNDERWENT ROBOTIC ASSISTED MESH EXCISION AND DRAINAGE OF RETROPERITONEAL COLLECTION UNDER GENERAL ANESTHESIA. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON IV ANTIBIOTICS. PATIENT READMITTED FOR CONTINUED BACK PAIN. RECEIVED PAIN MEDICATION AND MUSCLE RELAXERS AND ULTIMATELY UNDERWENT L4-L5 POSTERIOR ARTHRODESIS, L5-S1 POSTERIOR ARTHRODESIS, SEGMENTAL INSTRUMENTATION L4-S1 USING ALPHATEC INVICTUS, ATTACHMENT OF CAUDAL INSTRUMENTATION TO THE PELVIS USING S2 AI SCREWS ALPHATEC AND USE OF LOCAL AUTOGRAFT AND ALLOGRAFT SUPPLEMENTED WITH BMP UNDER GENERAL ANESTHESIA.

  Patient problems: Osteomyelitis; Pain; Unspecified Infection

  MAUDE report 24108935 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: IN AN EFFORT TO RECTIFY HER PELVIC ORGAN PROLAPSE, ON OR ABOUT(b)(6), 2024, PATIENT UNDERWENT A ROBOTIC LAPAROSCOPIC SACRAL COLPOPEXY PROCEDURE WITH INSERTION OF PUBOVAGINAL SLING TO TREAT HER PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE, ALONG WITH A HYSTERECTOMY, POSTERIOR COLPORRHAPHY AND CYSTOSCOPY. PATIENT IMPLANTED WITH ALTIS AND RESTORELLE XL. UNFORTUNATELY, COMPLICATIONS AROSE AFTER PATIENT WAS DISCHARGED. WITHIN A FEW WEEKS, PATIENT BEGAN EXPERIENCING DISCHARGE AT HER SUTURE LINES, AND POST-OPERATIVE PAIN AND FEVER. ON OR ABOUT (b)(6), 2024,PATIENT WENT TO EMERGENCY DEPARTMENT AND PATIENT WAS DIAGNOSED WITH VAGINAL DISCHARGE, URINARY TRACT INFECTION, FEVER, PAIN AND DISCHARGE FROM HER SUTURE LINES. ON OR ABOUT (b)(6),2025, PATIENT UNDERWENT A REMOVAL OF THE COLOPLAST ALTIS SLING TO RECTIFY ITS VAGINAL MESH EROSION AND URETHRAL OBSTRUCTION, DURING WHICH THE DOCTOR SUCCESSFULLY REMOVED THE ERODED MESH. PATIENT ALSO EXPERIENCED DYSPAREUNIA, AND DIFFICULTY WITH DAILY ACTIVITIES PRIOR TO THE SURGICAL INTERVENTION.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Dyspareunia; Fever; Obstruction/Occlusion; Pain; Pelvic Pain; Prolapse; Unspecified Infection; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 23991341 ↗
• InjuryJan 5, 2026Malposition of Device

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT ALSO EXPERIENCED URINARY URGENCY/FREQUENCY, NOCTURIA, FEELING OF INCOMPLETE BLADDER EMPTYING, RANDOM BLOOD IN TOILET AFTER SEX, DYSURIA AFTER SEX, URINARY TRACT INFECTIONS RESISTANT TO ANTIBIOTICS, DYSPAREUNIA, PERSISTENT URETHRAL BURNING (WORSE IN AM THEN IMPROVES), RECURRENT STRESS URINARY INCONTINENCE WITH FULL BLADDER, LEFT HIP PAIN AND MUSCLE SPASM/ HIGH-TONE PELVIC FLOOR DYSFUNCTION.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dyspareunia; Dysuria; Erosion; Hematuria; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 23960021 ↗
• MalfunctionNov 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, THE CUSTOMER DISCOVERED A [MESH] TEAR UPON OPENING THE PACKAGE. THE PRODUCT WAS NOT USED IN THE PATIENT. A NEW PRODUCT WAS OPENED AND SUCCESSFULLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526825 ↗
• InjurySep 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT ADDITIONALLY EXPERIENCED URINARY URGENCY, FREQUENCY, URINARY TRACT INFECTION, PELVIC DISCOMFORT WITH A PULLING SENSATION, BILATERAL LOW BACK PAIN WITHOUT SCIATICA. LEG SWELLING, PELVIC PAIN, LOWER BACK PAIN W/ PAIN DOWN BILATERAL LEGS, DULL SENSATION IN VAGINAL WALL. DYSPAREUNIA, CRAMPING, VAGINAL ODOR AND DISCHARGE, STRESS URINARY INCONTINENCE, BURNING/INTENSE MUSCLE SPASMS/CONTRACTIONS, UNABLE TO WALK. MOSTLY ON BED REST, DYSURIA, CONSTIPATION, DIARRHEA, AND REMOVAL OF MESH FROM OBTURATOR AND ADDUCTOR MUSCLE.

  Patient problems: Abnormal Vaginal Discharge; Abnormal scarring; Ambulation or Postural Difficulties; Atrophy; Burning Sensation; Constipation; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Diarrhea; Discomfort; Dyspareunia; Dysuria; Erosion; Inflammation; Pain; Pelvic Pain; Prolapse; Swelling/ Edema; Tactile Disorders; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 23142800 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A PATIENT EXPERIENCED A BOWEL INJURY [PERFORATION] DURING A RECENT SACROLPOPEXY. THE SURGEON PROCEEDED TO PLACE THE RESTORELLE XL AS NORMAL.

  Patient problems: Perforation

  MAUDE report 23051718 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WAS IMPLANTED WITH A RESTORELLE ON OR ABOUT (B)(6) 2015. THE PATIENT EXPERIENCED FOREIGN BODY REACTION, MESH PROTRUSION, MESH EROSION, PELVIC PAIN, BOWEL PROBLEMS, URINARY PROBLEMS, MENTAL AND PHYSICAL PAIN AND SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PERMANENT INJURY AND OTHER INJURIES. ON (B)(6) 2024, PATIENT UNDERWENT SURGERY TO REMOVE A PORTION OF THE MESH THAT HAD ERODED INTO PATIENT'S BLADDER.

  Patient problems: Abnormal Vaginal Discharge; Emotional Changes; Erosion; Fistula; Foreign Body Reaction; Hematuria; Micturition Urgency; Pain; Pelvic Pain; Prolapse; Urinary Incontinence; Urinary Retention

  MAUDE report 23015247 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD AN UNKNOWN TVT [TRANSVAGINAL TAPE] IMPLANTED IN 2013 AND A RESTORELLE DIRECT FIX IMPLANTED IN 2015. REPORTEDLY FROM 2019, THE PATIENT EXPERIENCED RIGHT FLANK PAIN, ABDOMINAL PAIN, MICROHEMATURIA, FREQUENCY, INCONTINENCE, PELVIC PAIN, URGENCY, HYPERTONICITY OF BLADDER, VAGINITIS, INFLAMMATION, POSTCOITAL BLEEDING, ABNORMAL VAGINAL BLEEDING, DETRUSOR HYPERREFLEXIA OF BLADDER, PAIN DURING SEX, OVERACTIVE BLADDER, BROWN VAGINAL DISCHARGE, BACTERIAL VAGINOSIS, ODOR, ATYPICAL GLANDULAR CELLS, BACTERIA MORPHOLOGICAL CONSISTENT WITH ACTINOMYCES SPECIES INFECTION, STRESS URINARY INCONTINENCE, EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL, RECURRENT RECTOCELE AND SCARRING. THE PATIENT UNDERWENT EXCISION OF EXPOSED VAGINAL MESH AND POSTERIOR COLPORRHAPHY VIA GENERAL ANESTHESIA. PATHOLOGY SHOWED SURGICAL MESH WITH ATTACHED INFLAMMATORY DEBRIS AND BACTERIAL COLONIES. POST EXCISION, THE PATIENT REPORTEDLY EXPERIENCED SPOTTING, MILD BLEEDING FROM PROLONGED STANDING, RECURRENT MESH EXPOSURE, PARTNER DYSPAREUNIA AND OVERACTIVE SYMPTOMS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Abnormal scarring; Bacterial Infection; Cramp(s) /Muscle Spasm(s); Dyspareunia; Erosion; Hematuria; Inflammation; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 22984454 ↗
• MalfunctionJul 30, 2025Material Disintegration; Material Disintegration

  ACCORDING TO THE AVAILABLE INFORMATION DURING PLACEMENT OF A RESTORELLE, THE DEVICE REPORTEDLY ¿DISINTEGRATED¿. THE RESTORELLE WAS PLACED ANTERIOR AND POSTERIOR AS USUAL AND SUTURED IN PLACE WITH RUNNING BARBED SUTURE. SURGEON PLACED SACRAL SUTURES AND NOTICED THAT IN THE MIDDLE OF THE SACRAL TAIL, THE INTEGRITY OF THE MESH SEEMED TO BE COMPROMISED AS THE MESH ON THE SACRAL TAIL APPEARED TO DISINTEGRATE. THE MESH WAS EXPLANTED, AND A SECOND MESH WAS PLACED WITH NO TROUBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666597 ↗
• InjuryJun 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED PROTRUSION OF THE MESH, EXTRUSION, EXCISION, BLEEDING, INFECTIONS, PELVIC FLOOR DISFUNCTION, PELVIC PAIN, VAGINAL PAIN, DYSPAREUNIA, URINARY URGENCY PROBLEMS, SCARRING, DIFFICULTY WITH DAILY ACTIVITIES, AND PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, WHICH ULTIMATELY REQUIRED SURGICAL INTERVENTION AND REMOVAL OF MESH.

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Kidney Infection; Micturition Urgency; Nervous System Injury; Pain; Pelvic Pain; Scar Tissue; Unspecified Infection; Urinary Retention

  MAUDE report 22341630 ↗
• InjuryJun 20, 2025Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT UNDERWENT A HYSTERECTOMY AND ROBOTIC SACROCOLPOPEXY SUCCESSFULLY WITH RESTORELLE. APPROXIMATELY 7 WEEKS POST OP, THE PATIENT FELT A "POP" AND SUBSEQUENTLY LOST THE VAGINAL APICAL SUPPORT SHE'D HAD POST SURGERY. A REVISION SURGERY WAS PERFORMED AND UPON INSPECTION THE RESTORELLE Y CONTOUR WAS NO LONGER HOLDING UP THE VAGINAL CUFF TO THE SACRAL PROMONTORY AND APPEARED TO BE DISCONNECTED SOMEWHERE BETWEEN THE SACRUM AND THE VAGINAL APEX. MESH AND SUTURES COULD BE SEEN AT THE PROMONTORY AND THE POSTERIOR ASPECT OF THE VAGINA UP TO THE VAGINAL CUFF. NO MESH WAS SEEN ON THE ANTERIOR VAGINAL WELL BUT THAT COULD HAVE BEEN THE DISSECTION PLANE USED BY THE SURGEON ON THE ANTERIOR SIDE. THE MESH POSTERIORLY WAS WELL INCORPORATED INTO HEALTHY VAGINAL TISSUE AND ONLY APPROXIMATELY ½ OF THE MESH WAS DISSECTED OUT. A NEW RESTORELLE MESH WAS IMPLANTED IN THE PATIENT SUCCESSFULLY. THE POSTERIOR ARM WAS IMPLANTED OVER THE PREVIOUSLY IMPLANTED AND INCORPORATED POSTERIOR ARM WHILE THE ANTERIOR ARM WAS SEWN ON WITH INDIVIDUAL SUTURES AND PULLED UP TO THE SACRUM IN THE NORMAL MANNER AND FIXATED WITH 2 PERMANENT "PROLENE" SUTURES.

  Patient problems: Prolapse

  MAUDE report 22299530 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED NAUSEA, VOMITING, ACUTE KIDNEY INJURY, SMALL BOWEL OBSTRUCTION CAUSED BY MESH ADHESION TO UTERINE AND SMALL BOWEL, ACUTE RENAL FAILURE WITH TUBULAR NECROSIS DUE TO POST-OP SMALL BOWEL OBSTRUCTION, SIGNIFICANT BILE EFFLUENT FROM NG "[NASOGASTRIC]", HIGH OUTPUT FROM NG, HYPOKALEMIA AND HYPOPHOSPHATEMIA. LAPAROSCOPIC REMOVAL OF MESH WAS PERFORMED.

  Patient problems: Abnormal scarring; Adhesion(s); Biliary Leak; Deformity/ Disfigurement; Dyspareunia; Electrolyte Imbalance; Emotional Changes; Erosion; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hypokalemia; Nausea; Necrosis; Obstruction/Occlusion; Pain; Pelvic Pain; Renal Failure; Unspecified Infection; Urinary Incontinence; Vomiting

  MAUDE report 22285492 ↗

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