Align® RS Retropubic/Suprapubic Urethral Support System without Dilator BRD301RSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741016202), received between Jul 15, 2019 and Nov 11, 2021 — classified as 7 injuries.

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 18, 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.

• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 30MAR2022, THE PATIENT HAS EXPERIENCED MESH EROSION, BLADDER STONE, URINARY PROBLEMS, ABDOMINAL PAIN AND URINARY TRACT INFECTION, URINARY INCONTINENCE, URINARY RETENTION, URINARY URGENCY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY, SUFFERED EMOTIONAL AND PSYCHOLOGICAL INJURIES AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Calcium Deposits/Calcification; Emotional Changes; Erosion; Incontinence; Pain; Urinary Retention; Urinary Tract Infection

  MAUDE report 12795776 ↗
• InjuryFeb 24, 2020Adverse 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 INJURY, PAIN, DISABILITY, IMPAIRMENT, OCCASIONAL CONSTIPATION, RIGHT LOWER QUADRANT PAIN, FEELING A BULGE IN HER VAGINA, PELVIC PAIN, VAGINAL PAIN, SCRATCHING OF HUSBAND¿S PENIS DURING INTERCOURSE, PAIN WITH SEXUAL INTERCOURSE, ABDOMINAL PAIN AFTER EXERCISING, MESH FIBROSIS AND TRIGGER POINT INJECTION. SHE REQUIRED NON-SURGICAL INTERVENTIONS AND A SURGICAL INTERVENTION WITH PARTIAL REMOVAL OF HER PUBOVAGINAL SLING AND ADDITIONAL ANESTHETIC INFILTRATED BEHIND THE PUBIC BONE AT THE AREA OF FIBROSIS AND MESH PLACEMENT, (DYSPAREUNIA), URGENCY, HEMATURIA, MILD ATROPHY OF THE VAGINAL MUCOSA, PALPABLE BANDING ON THE RIGHT PERIURETHRAL AREA AT THE AREA OF HER PREVIOUSLY PLACED SLING, TENDERNESS WITH PALPATION OF THE BLADDER, VAGINAL DISCHARGE, OVERACTIVE BLADDER, CHRONIC LOWER QUADRANT PAIN, CHRONIC SUPRAPUBIC PAIN, VAGINAL BLEEDING, STRESS URINARY INCONTINENCE WITH COUGHING OR SNEEZING AND QUESTIONABLE INTERSTITIAL CYSTITIS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9746494 ↗
• InjurySep 24, 2019Adverse 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: Injury

  MAUDE report 9110828 ↗
• InjurySep 6, 2019Adverse 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. PER ADDITIONAL INFORMATION RECEIVED THE PATIENT HAS EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE, INTRINSIC DEFICIENCY OF THE URETHRA, FAILED SLING, STRESS INDUCED DETRUSOR OVERACTIVITY, URETHRAL MOBILITY AND REQUIRED SURGICAL AND NONSURGICAL INTERVENTIONS.

  Patient problems: Incontinence; Injury

  MAUDE report 8969692 ↗
• InjurySep 6, 2019Adverse 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. PER ADDITIONAL INFORMATION RECEIVED THE PATIENT HAS EXPERIENCED A PREGNANCY WITH REPORTS OF THE SLING NOT WORKING AS WELL, URINARY INCONTINENCE WHILE DOING RIGOROUS EXERCISE AND REQUIRED NONSURGICAL INTERVENTIONS.

  Patient problems: Incontinence; Injury

  MAUDE report 8969691 ↗
• InjuryAug 23, 2019Adverse 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: Injury

  MAUDE report 8926536 ↗
• InjuryJul 15, 2019Adverse 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED A MALFUNCTIONING GENITOURINARY DEVICE, URGENCY URINARY INCONTINENCE, CYSTITIS, REMOVAL OF SLING TRANSVAGINALLY, CYSTOSCOPY, FOREIGN MATERIAL WITH ASSOCIATED CHRONIC INFLAMMATION, HISTIOCYTES, FIBROSIS, STRESS URINARY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY AND URETHRAL HYPERMOBILITY. SHE HAS REQUIRED NON-SURGICAL AND SURGICAL INTERVENTIONS.

  Patient problems: Foreign Body In Patient; Incontinence; Injury

  MAUDE report 8789076 ↗