Restorelle 501330Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05708932483285), received between Aug 30, 2021 and Jan 7, 2026 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryAug 31, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ADDITIONAL INFORMATION RECEIVED ON 04/19/2021. BRIGHT RED VAGINAL BLEEDING, DIARRHEA X 1 DAY, NOW WITH ONLY VAGINAL SPOTTING, MILD LEG PAIN, VAGINAL BURNING/PULLING L>R AFTER INTERCOURSE, INTERMITTENT DULL LEFT GROIN PAIN. SEVERE ABDOMINAL FULLNESS/PAIN WITH BLOATING, CONSTIPATION, FATIGUE SINCE ARIS/COLOPLAST IMPLANT. LEAKING URINE, USES 1 PAD/DAY, INCOMPLETE BLADDER EMPTYING, ABDOMINAL BLOATING. RIGHT LATERAL VAGINAL VAULT TENDER TO PALPATION. STATES ARIS IS NO LONGER WORKING, UI. PALPATION OF DISCRETE BAND THROUGH VAGINAL MUCOSA, SEVERE SUBURETHRAL TENDERNESS AT BLADDER NECK (R > L), DIFFUSE TENDERNESS THROUGHOUT PELVIC MUSCLES. MUI, URETHRAL HYPERMOBILITY. ON (B)(6) 2018 - EXCISION OF ARIS/COLOPLAST (COMPLETE ON RIGHT) (PARTIAL ON LEFT), BILATERAL TRANSVAGINAL URETHROLYSIS, REPAIR OF URETHRAL WALL GROOVE, CYSTOURETHROSCOPY. INTRAOPERATIVE FINDINGS: ARIS/COLOPLAST HAD MIGRATED HIGHER THAN THE BLADDER NECK, ALMOST TO TRIGONE LEVEL, LEFT SIDE OF SLING DEEPLY EMBEDDED INTO SURROUNDING TISSUES AT TRIGONE LEVEL AND CLOSE TO URETERIC ORIFICE, DEEP GROOVE IN URETHRAL WALL FOLLOWING EXCISION (REPAIRED). ED VISIT ¿ BACK/RIGHT HIP/RIGHT BUTTO

  Patient problems: Erosion; Pain; Scar Tissue

  MAUDE report 12389954 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ADDITIONAL INFORMATION RECEIVED ON 4/19/2021. 06/03/2021 08:52 AM (GMT-5:00) ADDED BY (B)(4): ADDITIONAL INFORMATION RECEIVED ON 04/19/2021. BACK PAIN, NEUROPATHIC PAIN OF PERINEUM. POSTOPERATIVE LOWER ABDOMINAL PAIN. ABDOMINAL AND SUPRAPUBIC PAIN. HYDRODISSECTION WITH MANNITOL COMPLETED. VAGINAL PAIN. RECEIVED SHOCK WAVE TREATMENT ON ABDOMEN. UTI MICROSCOPIC HEMATURIA, CYSTOSCOPY, DYSPAREUNIA, PELVIC PAIN. EXAM UNDER GENERAL ANESTHESIA. CYSTOSCOPY SHOWED BLADDER BASE INDURATION, ERYTHEMA, AND PURULENT EXUDATIVE PROCESS AT THE PERIPHERY. SERIAL URINALYSIS SHOW WORSENING PYURIA AND MICROSCOPIC HEMATURIA SOMETIMES WITHOUT POSITIVE CULTURES. NO FRANK MESH EROSION, BUT SUSPECTED THAT MESH MAY BE MIGRATING INTO BLADDER WALL AND CAUSING THESE REACTIONARY CHANGES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 12389909 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ADDITIONAL INFORMATION RECEIVED ON 04/28/2021.(B)(6) 2012: RESTORELLE XL USED FOR SACROCOLPOPEXY WITH PROLENE AND ETHIBOND SUTURES, LYSIS OF ADHESIONS. INTRAOPERATIVE FINDINGS: RECTOVAGINAL SPACE SCARRING PRESUMED FROM PRIOR EPISIOTOMY/SURGICAL PROCEDURE, DENUDED POSTERIOR VAGINAL EPITHELIUM (TRIMMED), MAINLY OMENTAL ADHESIONS TO MIDLINE RIGHT ANTERIOR ABDOMINAL WALL. SEVERE VAGINAL PAIN/IRRITATION, VAGINAL BLEEDING, GOLF BALL SIZE VAGINAL LUMP WITH YELLOW DISCHARGE/ODOR X 3 MONTHS. POSTERIOR VAGINAL VAULT RESTORELLE XL EXPOSURE AT 6:00, FLESH COLORED/SOFT VAGINAL LUMP WITH YELLOW ODOROUS DISCHARGE ADJACENT TO RESTORELLE XL/COLOPLAST EXPOSURE THAT IS TENDER TO PALPATION, SMALL ERYTHEMATOUS LESION AT 11:00 ABOVE CERVIX THAT IS NON-TENDER TO PALPATION, ACUTE BACTERIAL VAGINITIS.

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Genital Bleeding; Pain

  MAUDE report 12389486 ↗