Align® TO Trans-Obturator Urethral Support System - Hook & Halo without Dilator BRD601HHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741016240), received between May 2, 2018 and Dec 26, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2020Adverse 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 PELVIC PAIN, DYSPAREUNIA, MESH EXPOSURE, LESIONS, EROSIONS, VOIDING DYSFUNCTION, SPASM AT LEVATOR MUSCLES, PERSISTENT PAIN, STRESS URINARY INCONTINENCE, URGENCY, LEAKS, FREQUENCY, URGENCY, URGE INCONTINENCE, PAIN AT IMPLANT SITE, HYPERMOBILE URETHRA, SEVERE PAIN IN VAGINA, WITH MESH COMING OUT, DYSURIA, BENIGN HYPERTENSION, URINARY FREQUENCY INCREASED, PAIN IN RIGHT FOOT, HIATAL HERNIA, URINARY TRACT INFECTION, BURNING WITH URINATION, PAIN IN THE FLANK, IRRITATION, PALPABLE INDURATED AREA SURROUNDING THE DISTAL URETHRA CONSISTENT WITH SCAR TISSUE AND PROBABLE RESIDUAL MESH. THE PATIENT REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 11073803 ↗
• 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PERSISTENT STRESS URINARY INCONTINENCE. SHE HAS REQUIRED ONE SURGICAL INTERVENTION.

  Patient problems: Injury

  MAUDE report 8926539 ↗
• InjuryJul 3, 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 VAGINAL BLEEDING, A CLOT AT THE INTROITUS, HEMATURIA, LOW BACK PAIN, RARE CONSTIPATION, OCCASIONAL INCOMPLETE EMPTYING, FREQUENCY, NOCTURIA, OCCASIONAL URGENCY INCONTINENCE, BLADDER INFECTION, URETHRAL MEATUS DIFFICULT TO SEE DUE TO STENOSIS, PALPABLE MESH ALONG URETHRA, ATROPHIC VAGINITIS, EROSION OF IMPLANTED MESH, AND REQUIRED NONSURGICAL INTERVENTIONS. REASON FOR REPORT: REVOCATION OF ASR, REPORT ID NUMBER: (B)(4), CORRESPONDING EXEMPTION NUMBER: E2013025.

  Patient problems: Hematuria; Injury; Intermenstrual Bleeding

  MAUDE report 8760467 ↗
• InjuryMay 2, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT HAD A DEVICE IMPLANTED ON (B)(6) 2012. SINCE THAT TIME THE PATIENT HAS EXPERIENCED PAIN, TWO BRAIN CYSTS FROM CONSTANTLY BEING DIZZY, DYSPAREUNIA, DEPRESSION, INSOMNIA, AND BLOODY DISCHARGE. THE PATIENT STATED THAT "SHE TAKES 2 PILLS A NIGHT TO STAY ALIVE."

  Patient problems: Abnormal Vaginal Discharge; Cyst(s); Pain

  MAUDE report 7480803 ↗