Restorelle 501440Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05708932483964), received between Jun 7, 2022 and Oct 16, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, A RESTORELLE MESH WAS IMPLANTED IN (B)(6) 2018. FROM 2022, THE PATIENT WITH THIS DEVICE EXPERIENCED: RECURRENT VAGINAL KLEBSIELLA, RECTOCELE, ABDOMINAL PAIN, CYSTOCELE-MIDLINE, BACK PAIN, PAIN WITH PROLONGED SITTING, PELVIC PAIN AND UNDERWENT REMOVAL OF PELVIC MESH, HARVEST OF RECTUS FASCIA, ABDOMINAL SACRAL COLPOPEXY USING AUTOLOGOUS RECTUS FASCIA, POSTERIOR AND PERINEAL REPAIR AND BILATERAL OOPHORECTOMY VIA GENERAL ANESTHESIA. RECURRENT RECTOCELE, INABILITY TO HAVE SEX AND FEELING OF BRUISED LOWER ABDOMEN WERE REPORTED POST PROCEDURE.

  Patient problems: Discomfort; Pain; Prolapse; Sexual Dysfunction; Unspecified Infection

  MAUDE report 20462486 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT REPORTEDLY HAD A RESTORELLE SLING IMPLANTED IN (B)(6) 2019 AND AN ALTIS MESH IMPLANTED ON AN UNKNOWN DATE. REPORTEDLY THE PATIENT HAD RECURRENT CYSTOCELE REQUIRING COLPORRHAPHY UNDER GENERAL ANESTHESIA, RECURRENT VAGINAL WALL PROLAPSE, CHRONIC PELVIC PAIN, DYSPAREUNIA AND HEMATURIA. THE RESTORELLE SLING WAS EXPLANTED IN (B)(6) 2020. IN (B)(6) 2022 MESH WAS IDENTIFIED NEAR THE VAGINA. ROBOTIC SACROCOLPOPEXY, MESH EXCISION [ALTIS] AND CYSTOSCOPY UNDER GENERAL ANESTHESIA WAS PERFORMED. THE PATIENT REPORTEDLY EXPERIENCED STRESS URINARY INCONTINENCE IN 2022.

  Patient problems: Dyspareunia; Hematuria; Pelvic Pain; Prolapse; Urinary Incontinence

  MAUDE report 20386650 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED EXPOSURE, DISCHARGE, INFLAMMATION, PROLAPSE, URGENCY URINARY INCONTINENCE, URINARY FREQUENCY, URINARY INCONTINENCE, UTI AND A REVISION OF THE MESH EXPOSURE.

  Patient problems: Abnormal Vaginal Discharge; Foreign Body Reaction; Incontinence; Inflammation; Micturition Urgency; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 18664021 ↗
• InjuryJan 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ADDITIONAL INFORMATION RECEIVED ON 6/6/2023 AS FOLLOWS: THE PATIENT EXPERIENCED ANEMIA REQUIRING TRANSFUSION, UNCLEAR IF RELATED TO RECENT CYSTOSCOPY AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Anemia; Constipation; Decreased Appetite; Diarrhea; Discomfort; Dyspareunia; Erosion; Intermenstrual Bleeding; Kidney Infection; Micturition Urgency; Nausea; Pain; Prolapse; Skin Tears; Urinary Incontinence; Weight Changes

  MAUDE report 16274955 ↗
• InjuryJan 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED CONSTIPATION, ABDOMINAL DISTENSION, NO URGE TO VOID AND UNABLE TO FEEL WHEN URINATING, URINARY RETENTION, PROGRESSIVE URINARY RETENTION, PAIN, URINARY URGENCY, NOCTURIA, URINARY DIFFICULTY, URINARY FREQUENCY, UNABLE TO FEEL URGE TO DEFECATE IN LOWER ABDOMEN, URINARY TRACT INFECTIONS, URINARY DYSSYNERGIA, CHRONIC FATIGUE, PELVIC FLOOR DYSFUNCTION, AND DYSURIA. PATIENT HAD REVISION OF THE DEVICE WITH TRANSECTION AND CYSTOSCOPY UNDER GENERAL ANESTHESIA.

  Patient problems: Abdominal Distention; Constipation; Cramp(s) /Muscle Spasm(s); Dysuria; Fatigue; Kidney Infection; Micturition Urgency; Numbness; Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 16084092 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED DEVICE EROSION, DYSPAREUNIA, CHRONIC PELVIC PAIN, AND DEVICE EXPLANTATION.

  Patient problems: Dyspareunia; Erosion; Fecal Urgency; Hematuria; Kidney Infection; Pain; Prolapse; Urinary Incontinence

  MAUDE report 15926703 ↗
• InjuryJun 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED THE FOLLOWING SYMPTOMS AND PROCEDURES ON THE ACCORDING DATES: (B)(6) 2017: STAGE-II ANTERIOR VAGINAL WALL PROLAPSE, STAGE-I VAGINAL VAULT PROLAPSE AFTER HYSTERECTOMY, STAGE-II POSTERIOR VAGINAL WALL PROLAPSE, PUBOCERVICAL AND RECTOVAGINAL FASCIAL WEAKNESS, INCOMPLETE BLADDER EMPTYING, WEAK URINARY STREAM, SIGNIFICANT REDUNDANCY OF THE COLON. ROBOTIC-ASSISTED LAPAROSCOPIC SACROCOLPOPEXY, LAPAROSCOPIC-ASSISTED ABDOMINAL CYSTOCELE REPAIR, POSTERIOR REPAIR, ROBOTIC-ASSISTED LEFT SALPINGECTOMY, CYSTOURETHROSCOPY TO EVALUATE VOIDING DYSFUNCTION, ENTEROCELE REPAIR UNDER GENERAL ANESTHESIA. (B)(6) 2019: STAGE I VAGINAL VAULT PROLAPSE, PELVIC PRESSURE, PELVIC FLOOR WEAKNESS, BACTERIAL VAGINOSIS, INCOMPLETE BLADDER EMPTYING, UTI, URGE INCONTINENCE, DYSPAREUNIA, ATROPHIC VAGINITIS. (B)(6) 2019: DYSPAREUNIA, VAGINISMUS, MESH EROSION, URETHRAL CARUNCLE. (B)(6) 2019: DYSPAREUNIA, MESH EROSION, CHRONIC VAGINAL INFECTIONS. (B)(6) 2019: MECHANICAL MALFUNCTION OF GU DEVICE, MESH EROSION, DYSPAREUNIA. LAPAROSCOPIC MESH EXCISION AND CYSTOSCOPY UNDER GENERAL ANESTHESIA. (B)(6) 2019: URINARY RETENTION. (B)(6) 2019: M

  Patient problems: Bacterial Infection; Dyspareunia; Micturition Urgency; Pain; Skin Erosion; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 14627550 ↗