Advantage™ Blue System M0068502050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729961918), received between May 5, 2021 and Aug 28, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING UNPACKING, THE STERILIZED CONTAINER APPEARED TO BE COMPROMISED, AS THE PACKAGE SEAL LOOKED BROKEN UPON OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920055 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE BLUE SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2023, DURING A PROCEDURE. ON (B)(6) 2023, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION AND WAS TREATED WITH ANTIBIOTICS. THE INFECTION REOCCURRED ON (B)(6) 2023, AND WAS TREATED AGAIN WITH ANTIBIOTICS. THE PATIENT EXPERIENCED BURNING OF THE VULVA, LABIA MAJORA, PERINEUM, AND VAGINA, ALONG WITH PELVIC PAIN. THE PATIENT CURRENTLY FINDS IT IMPOSSIBLE TO SIT DOWN. SHE IS ALSO EXPERIENCING PAIN, INSOMNIA, ASTHENIA, AND ANXIETY.

  Patient problems: Anxiety; Burning Sensation; Fatigue; Pain; Sleep Dysfunction; Urinary Tract Infection; Weight Changes

  MAUDE report 17379090 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE BLUE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2009. AS A RESULT OF THE IMPLANTATION OF THE PRIOR DESIGNATED PELVIC MESH PRODUCT, THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING INJURIES: INFECTIONS, PELVIC PAIN, BACK PAIN, HIP PAIN, LEG PAIN, NERVE DAMAGE, PROLAPSE, FAILED SLING, DYSPAREUNIA, STRESS AND URGE INCONTINENCE, MESH EROSION, LOSS OF A SPOUSE, AND MORE TO BE DETERMINED DURING THE COURSE OF DISCOVERY. FURTHERMORE, THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING DAMAGES AS A RESULT OF THE PRIOR DESIGNATED PELVIC MESH PRODUCT'S IMPLANTATION: ECONOMIC DAMAGES SUCH AS MEDICAL BILLS, OUT-OF-POCKET EXPENSES, AND LOST WAGES; AS WELL AS NON-ECONOMIC DAMAGES SUCH AS PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, ANXIETY, DEPRESSION, PHYSICAL IMPAIRMENT, AND PERMANENT PHYSICAL INJURY. ADDITIONAL INFORMATION RECEIVED ON JUNE 27, 2023: PRE-OPERATIVELY THE PATIENT WAS DIAGNOSED WITH MENORRHAGIA AND GENUINE STRESS URINARY INCONTINENCE FOR THE TENSION-FREE VAGINAL TAPE THROUGH TRANSOBTURATOR SPACE, CYSTOSCOPY, DILATION AND CURETTAGE, HYSTERECTOMY, AND ENDOMETRIAL ABLATION PRO

  Patient problems: Abnormal Vaginal Discharge; Anxiety; Calcium Deposits/Calcification; Depression; Dyspareunia; Erosion; Fistula; Hematoma; Hematuria; Hemorrhage/Blood Loss/Bleeding; Inflammation; Micturition Urgency; Nerve Damage; Pain; Prolapse; Purulent Discharge; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 16813065 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE BLUE SYSTEM DEVICE WAS IMPLANTED IN A PROCEDURE ON (B)(6) 2022, FOR THE TREATMENT OF URINARY INCONTINENCE. ON (B)(6) 2022, THE PATIENT BEGAN TO EXPERIENCE VAGINAL PAIN AND CONSTANT URINARY TRACT INFECTION. THE PATIENT HAS BEEN TAKING ANTIBIOTICS FOR FOUR MONTHS AS PRESCRIBED BY THE PHYSICIAN. ADDITIONALLY, THE PATIENT IS UNABLE TO TRAVEL LONG DISTANCE BECAUSE SHE GOES TO THE TOILET FREQUENTLY. SHE ALSO OFTEN WAKES UP AT NIGHT TO GO TO THE BATHROOM. THE PATIENT CLAIMS TO BE PERMANENTLY ON ANTIBIOTICS BECAUSE HER UTI KEEPS RECURRING, BUT WHEN SHE TESTS HERSELF, THERE ARE NO RESULTS.

  Patient problems: Pain; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 16294642 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE BLUE SYSTEM WAS USED DURING A MIDURETERAL ADVANTAGE SLING AND CYSTOSCOPY PROCEDURES PERFORMED ON (B)(6) 2019 TO TREAT A PATIENT WITH STRESS URINARY INCONTINENCE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15156736 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE BLUE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A RETROPUBIC MIDURETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2019 FOR THE TREATMENT OF STRESS INCONTINENCE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14422382 ↗
• InjuryMay 5, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE BLUE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A MID-URETHRAL SLING PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021 TO TREAT STRESS URINARY INCONTINENCE. WHEN THE PATIENT WAS LEAKING URINE AFTER THE PROCEDURE THEY DISCOVERED BLADDER PERFORATION AND REMOVED THE MESH ON (B)(6) 2021. THE PATIENT WAS THEN RESCHEDULED FOR A NEW MESH IMPLANT (ADVANTAGE BLUE SYSTEM) THREE MONTHS LATER. PRIOR TO THE NEW IMPLANT, BLADDER STONE CAUSED BY THE FRAGMENTS OF THE ORIGINAL MESH WAS DISCOVERED VIA CYSTOSCOPY AND WAS REMOVED. SUBSEQUENTLY, THE PATIENT HAD THE NEW MID-URETHRAL SLING IMPLANTED. REPORTEDLY, THE ISSUE HAS BEEN RESOLVED AND THE PATIENT'S CURRENT CONDITION IS GOOD.

  Patient problems: Internal Organ Perforation; Obstruction/Occlusion; Urinary Incontinence

  MAUDE report 11778222 ↗