Restorelle 501430Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708932483896), received between Oct 19, 2021 and Jul 7, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, 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 12, 2023Positioning Failure; Migration or Expulsion of Device; Positioning Failure; Migration or Expulsion of Device

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED INCOMPLETE EMPTYING, BLADDER OUTLET OBSTRUCTION, INCONTINENCE, STRESS URINARY INCONTINENCE, RECURRENT URINARY TRACT INFECTIONS, BLADDER PERFORATION OF SACROCOLPOPEXY DEVICE. PATIENT HAD A MIDURETHRAL DEVICE IMPLANTED FOR SEVERE STRESS URINARY INCONTINENCE. PATIENT HAD A CYSTOSCOPY AND IT REVEALED EROSION AND/OR PERFORATION OF SACROCOLPOPEXY DEVICE THROUGH THE BLADDER WALL IN THE POSTERIOR BLADDER WALL WITH MULTIPLE SKIN BRIDGES ON THE POSTERIOR BLADDER WALL. PATIENT HAD A URODYNAMIC STUDY PERFORMED AND IT REVEALED A VERY LARGE BLADDER CAPACITY WITH DECREASED SENSATION. PATIENT WAS UNABLE TO VOID FOR THE STUDY, AND HER RESIDUAL WAS 560 ML. PATIENT HAD AN MRI AND IT REVEALED BLADDER PERFORATION OF SACROCOLPOPEXY DEVICE. PATIENT HAD ROBOTIC EXPLANTATION OF THE SACROCOLPOPEXY DEVICE, CYSTOTOMY REPAIR, CYSTOSCOPY WITH BILATERAL URETERAL STENT PLACEMENT, EXPLANTATION OF TRANSVAGINAL MIDURETHRAL DEVICE AND CYSTOSCOPY UNDER GENERAL ANESTHESIA. INTRAOPERATIVE NOTES INDICATED THAT THE SACROCOLPOPEXY DEVICE HAD BEEN FIXED TO THE BLADDER ITSELF, AND THE PLANE BETWEEN THE BLADDER

  Patient problems: Erosion; Hyporesponsive to stimuli; Internal Organ Perforation; Urethral Stenosis/Stricture; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 16147413 ↗
• InjuryOct 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ADDITIONAL INFORMATION RECEIVED ON 04/22/2021. URGE TO URINATE, HESITANCY AND UNABLE TO EMPTY FULLY WITH URINATION, CRAMPING WITH DEFECATION, R INGUINAL PAIN, NUMBNESS AND TINGLING IN THE UPPER ANTERIOR AND LATERAL R THIGH. MULTIPLE PT SESSIONS FOR MUSCLE SPASMS/PELVIC FLOOR MYALGIA AND POOR URINARY STREAM. (B)(6) 2018 - PRE-OP DIAGNOSES OF HISTORY OF PRIOR LAPAROSCOPIC PROLAPSE REPAIR X 2, HISTORY OF PRIOR APICAL VAGINAL MESH EROSION WITH REVISION, RECURRENT ANTERIOR APICAL VAGINAL MESH EXPOSURE AND RECURRENT CYSTOCELE. VAGINAL EXCISION OF MESH AND ANTERIOR COLPORRHAPHY AND CYSTOSCOPY. DYSURIA. LEGAL REPRESENTATIVE STATED SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE AND REQUIRED REVISION SURGERY IN (B)(6) 2018. OPERATIONS TO ATTEMPT TO LOCATE AND REMOVE MESH, REPAIR PELVIC ORGANS, TISSUE, AND NERVE DAMAGE, THE USE OF PAIN CONTROL AND OTHER MEDICATIONS, INJECTIONS INTO VARIOUS AREA OF THE PELVIS, SPINE AND THE VAGINA AND OPERATORS TO REMOVE PORTIONS OF THE FEMALE GENITALIA. URINARY INCONTINENCE, PHYSICAL DEFORMITY AND THE LOSS OF THE ABILITY TO PERFORM SEXUALLY.

  Patient problems: Deformity/ Disfigurement; Dyspareunia; Incontinence; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 12658074 ↗