Obtryx™ II System - Halo M0068505110Recalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 08714729837565), received between Nov 17, 2016 and May 14, 2026 — classified as 1 death, 163 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 reports).

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 25 most recent of 196 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY PROCEDURE WHERE AN OBTRYX II SYSTEM - HALO WAS IMPLANTED ON (B)(6) 2018, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. DURING THE SAME PROCEDURE, BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY, MCCALL CULDOPLASTY, POSTERIOR VAGINAL REPAIR, TRANSOBTURATOR MIDURETHRAL SLING AND CYSTOSCOPY WERE ALSO PERFORMED. FOLLOWING THE IMPLANTATION, ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH COMPLICATION OF THE VAGINAL MESH, RECTOCELE, PELVIC RELAXATION DUE TO MIDLINE CYSTOCELE, DISEASE OF URINARY TRACT, EXPOSED TRANSVAGINAL MESH, AND DYSPAREUNIA. SHE UNDERWENT CYSTOSCOPY, EXCISION OF VAGINAL MESH, TRANSVAGINAL REMOVAL OF TOT (TRANSOBTURATOR) MESH SLING, ANTERIOR AND POSTERIOR COLPORRHAPY REPAIR WITH PERINEAL REPAIR, VAGINAL RECONSTRUCTION AFTER SLING REMOVAL AND RECTOCELE REPAIR. THE PATIENT HAD EXPERIENCED PAIN IN THE VAGINAL AREA, DYSPAREUNIA, AND EXPOSED AND PRESUMED INFECTED FOREIGN BODY IN THE VAGINAL CAVITY. DURING THE PROCEDURE, THE MESH WAS FOUND TO BE EXPOSED, SUGGESTING THAT THE VAGINAL TISSUE MAY HAVE BEEN BUTTONHOLED DURING THE ORIGINAL TOT PLACEMENT. A SECTION LATERAL TO THE MIDLIN

  Patient problems: Dyspareunia; Erosion; Pain; Prolapse; Unspecified Infection; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 25167130 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANT PROCEDURE ON (B)(6) 2020, IN WHICH AN OBTRYX II SYSTEM - HALO WAS PLACED FOLLOWING A LONG HISTORY OF MIXED INCONTINENCE THAT HAD WORSENED OVER THE YEARS. THE PATIENT NOTED THAT PRIOR TO THE PLACEMENT, SHE WOULD EXPERIENCE NOCTURIA AND LEAKAGE WORSENED WITH PHYSICAL ACTIVITY, COUGHING AND SNEEZING. ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH HYPERMOBILITY OF THE URETHRA, MIXED INCONTINENCE, AND CYSTOCELE; THEREFORE, A REVISION SURGERY WAS PERFORMED. DURING THE PROCEDURE, A PINHOLE DEFECT WAS IDENTIFIED IN THE ANTERIOR VAGINAL WALL AT APPROXIMATELY THE MID-VAGINAL LEVEL. AN INCISION WAS MADE, REVEALING PURULENCE AND DISCHARGE SURROUNDING THE PREVIOUSLY PLACED SLING. THE MESH WAS NOT ENCAPSULATED AND WAS EASILY VISIBLE. THE SLING WAS REMOVED WITH GENTLE TRACTION, AND THE TRANSOBTURATOR ARMS WERE EXCISED USING TENOTOMY SCISSORS. FOLLOWING REMOVAL, NECROTIC DEBRIS WAS OBSERVED ALONG THE SLING BED, AND THOROUGH DEBRIDEMENT OF NECROTIC TISSUE WAS PERFORMED. THE PLACEMENT OF A NEW SLING WAS ABANDONED DUE TO THE PRESENCE OF ACTIVE INFECTION. THE VAGINAL MUCOSAL EDGES WERE REFRESHED BY EXCISING THE INCISION MARGINS, AFTER WHICH THE VAG

  Patient problems: Abscess; Incontinence; Necrosis; Prolapse; Purulent Discharge; Unspecified Infection; Unspecified Kidney or Urinary Problem

  MAUDE report 24335168 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX II SYSTEM - HALO IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING INFECTION, SEVERE PELVIC CRAMPING AND PAIN, BLEEDING, PURULENCE, NECROTIC TISSUE, ABSCESS, RECURRENCE, REMOVAL AND DEBRIDEMENT OF NECROTIC TISSUE, AND SUBSEQUENT REMOVAL SURGERY. THE PATIENT LATER UNDERWENT A REVISION SURGERY ON OR ABOUT (B)(6) 2024. AS A RESULT OF THE IMPLANTED DEVICE, THE PATIENT SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSES, EMBARRASSMENT, DISFIGUREMENT, AND HARM. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY HAVE TO UNDERGO FURTHER SURGERY AND MAY, IN THE FUTURE, SUFFER DAMAGES SUCH AS SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND ADDITIONAL MEDICAL EXPENSES RELATED TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abscess; Deformity/ Disfigurement; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Necrosis; Pain; Purulent Discharge; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 23871402 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX II SYSTEM - HALO IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING MESH EROSION AND EXPOSURE, VAGINAL SPOTTING, VAGINAL DISCHARGE, DYSURIA, DYSPAREUNIA, CHRONIC ABDOMINAL PAIN REQUIRING TREATMENT WITH TRIGGER POINT INJECTIONS, ATROPHIC VAGINITIS, CHRONIC MIGRAINES, PELVIC PAIN, BACK PAIN, AND LIMB PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT A MESH REVISION SURGERY ON (B)(6) 2023. THE PATIENT SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSE, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTED DEVICE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY HAVE TO UNDERGO ADDITIONAL SURGERY, AND MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS, SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY INJURY, MENTAL AND PHYSICAL PAIN AND SUFFERING, MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Deformity/ Disfigurement; Dyspareunia; Dysuria; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 23761850 ↗
• MalfunctionDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE, THE DEVICE BROKE WHILE BEING REPOSITIONED INSIDE THE PATIENT. THE "ANCHOR" DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758026 ↗
• MalfunctionNov 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A PROCEDURE USING AN OBTRYX II SYSTEM, THE SLING BROKE WHILE BEING PULLED INTO POSITION, WHILE NOTING THAT THE PATIENT HAD DIFFICULT ANATOMY. THE EVENT IS UNCLEAR AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. THE EVENT DESCRIPTION MAY SUGGEST THAT THE MESH WAS TORN. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645586 ↗
• MalfunctionSep 15, 2025Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING AN OBTRYX II SYSTEM - HALO DEVICE, THE MESH BECAME TWISTED UPON INSERTION. WHEN THE PHYSICIAN ATTEMPTED TO STRAIGHTEN IT, THE MESH FRACTURED INTO TWO PIECES. BOTH FRAGMENTS WERE REMOVED, AND 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 23058152 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANS OBTURATOR TAPE PROCEDURE USING AN OBTRYX? II SYSTEM - HALO DEVICE, THE MESH WAS NOTED TO BE BROKEN. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915766 ↗
• InjuryAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANS OBTURATOR TAPE PROCEDURE USING AN OBTRYX? II SYSTEM - HALO DEVICE, THE MESH WAS NOTED TO BE BROKEN. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887275 ↗
• MalfunctionAug 21, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT AN OBTRYX II SYSTEM - HALO DEVICE WAS USED DURING A PERIURETHRAL DISSECTION AND URETHRAL FOLEY CATHETER INSERTION. AFTER BLADDER EMPTYING, MULTIPLE ATTEMPTS WERE MADE TO PASS THE LEFT HALO NEEDLE FOR PLACEMENT OF THE PERIURETHRAL MESH INTENDED TO CORRECT URINARY INCONTINENCE. HOWEVER, THESE WERE UNSUCCESSFUL. THE PROCEDURE WAS THEN ABORTED. THE FOLEY CATHETER WAS LEFT INDWELLING, AND THE ANTERIOR VAGINAL INCISION, ALONG WITH THE OBTURATOR FOSSA ENTRY POINTS, WERE CLOSED. THE PHYSICIAN THEN PROCEEDED TO COMPLETE THE VAGINAL PROLAPSE REPAIR USING SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861107 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN PAIN-FREE FOLLOWING A TRANS OBTURATOR TAPE (TOT) PROCEDURE IN 2020 USING AN OBTRYX II SYSTEM - HALO DEVICE. HOWEVER, IN LATE (B)(6) 2025, THE PATIENT BEGAN EXPERIENCING A URINARY TRACT INFECTION (UTI) ACCOMPANIED BY VARIOUS TYPES OF PAIN, INCLUDING VAGINAL PAIN, LEG PAIN, AND PAIN IN THE LEFT BUTTOCK, AS WELL AS A BURNING SENSATION IN THE BLADDER. DESPITE MULTIPLE MEDICAL CONSULTATIONS AND TREATMENT WITH PAINKILLERS AND ANTI-INFLAMMATORY MEDICATIONS, THE PATIENT'S SYMPTOMS PROGRESSIVELY WORSENED AND EVENTUALLY BECAME UNBEARABLE. CLINICAL OBSERVATION REVEALED THAT THE LEFT SIDE OF THE SLING WAS LOCATED IN CLOSE PROXIMITY TO THE VAGINAL WALL, AND THE PATIENT EXPERIENCED PAIN IN THE REGION OF THE LEFT OBTURATOR FORAMEN. DUE TO THE PERSISTENT AND SEVERE NATURE OF THE SYMPTOMS, THE PATIENT UNDERWENT SURGICAL REMOVAL OF THE LEFT PORTION OF THE SLING ON (B)(6) 2025.

  Patient problems: Burning Sensation; Pain; Urinary Tract Infection

  MAUDE report 22621080 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OBTRYX II SYSTEM HALO DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PREVIOUS PROCEDURE. SOMETIME AFTER THE PROCEDURE, THERE WAS MESH EROSION INTO THE BLADDER WITH CALCIFICATION ON THE RIGHT SIDE. IT WAS NOTED THAT THE PATIENT UNDERWENT A SURGERY WITH COMPLICATIONS; THERE WAS BLEEDING AT THE END OF THE PROCEDURE, AND THEY HAD TO OPEN THE APONEUROSIS OF THE RECTUS SHEATH TO CLOSE THE BLADDER. THREE WEEKS FOLLOWING THE INTERVENTION, THE PATIENT DEVELOPED A FISTULA, RESULTING IN TWO CATHETERS, A CYSTOCATH AND A URINARY CATHETER, BEING PLACED. SINCE THE INITIAL SYMPTOMS, THE PATIENT CONTINUED EXPERIENCING PAIN AND URINARY TRACT INFECTIONS. IT WAS NOTED THAT PAIN MANAGEMENT ATTEMPTS HAVE NOT BEEN EFFECTIVE. THERE HAVE NOT BEEN ANY REPORTED FURTHER ACTIONS TO MANAGE THE SYMPTOMS.

  Patient problems: Calcium Deposits/Calcification; Erosion; Fistula; Hemorrhage/Blood Loss/Bleeding; Pain; Urinary Tract Infection

  MAUDE report 22299026 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX II SYSTEM - HALO. AS A RESULT OF THE MESH IMPLANT, IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED DYSPAREUNIA, CHRONIC AND SEVERE PELVIC PAIN, MENTAL AND PHYSICAL PAIN, PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE AND LIKELY WILL UNDERGO FURTHER CORRECTIVE SURGERY OR SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES. ON (B)(6) 2022, THE PATIENT UNDERWENT A PELVIC EXAMINATION, IN WHICH IT WAS NOTED THAT THE SLING WAS PALPABLE AT THE INTROITUS. IN (B)(6) 2023, THE PATIENT PRESENTED PELVIC PAIN AND VAGINAL BLEEDING. EXAMINATION REVEALED TENDERNESS ALONG THE MESH. ADDITIONALLY, THEY NOTED AN AREA OF GRANULATION THAT HAD NOT BEEN IDENTIFIED PRIORLY. ON (B)(6) 2023, THE PATIENT UNDERWENT REMOVAL SURGERY OF THE SLING AND A CYSTOSCOPY. IT WAS NOTED THAT THE PAIN AND BLEEDING WAS LIKELY RELATED TO THE DEVICE. BY (B)(6) 2024, THE PATIENT HAD COMPLETED TWO MONTHS OF PELVIC FLOOR PHYSICAL THERAPY; HOWEVER, SYMPTOMS OF STRESS URINARY INCONTINENCE, BLADDER PAIN, GROIN PAIN AND LEG NUMBNESS STARTED TO WORSEN. A PELVIC MAGNE

  Patient problems: Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Numbness; Pain; Swelling/ Edema; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 22179446 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, SOMETIME AFTER IMPLANTATION, AROUND (B)(6) 2024, THE PATIENT EXPERIENCED DYSPAREUNIA AND EXTRUSION AT THE RIGHT VAGINAL FORNIX. AS A RESULT, THE EXPOSED MESH HAD BEEN EXCISED.

  Patient problems: Dyspareunia; Erosion

  MAUDE report 22062019 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOMETIME AFTER IMPLANTATION, THE PATIENT HAD RECURRING URINARY TRACT INFECTIONS (UTI), PYELONEPHRITIS, A MALFUNCTIONING BLADDER, AND URINARY RETENTION OF 400 ML TO 600 ML. SHE ALSO REPORTED PERSISTENT VULVAR PAIN, LEFT-SIDED STIFFNESS, PAIN BETWEEN THE THIGHS, AND SHOOTING PAINS IN THE LEFT SIDE AND UPPER THIGHS. SHE WAS HOSPITALIZED AND RECEIVED ANTIBIOTIC TREATMENTS, INCLUDING INJECTIONS MORE THAN THREE TIMES ANNUALLY, IN ADDITION TO ORAL ANTIBIOTICS. SINCE OCTOBER 2023, THE FREQUENCY OF UTI AND PAIN HAS INCREASED. UNDER HER PHYSICIAN'S SUPERVISION, SHE HAS BEEN PERFORMING SELF-CATHETERIZATION THREE TIMES DAILY SINCE ON (B)(6) 2025.

  Patient problems: Pain; Unspecified Infection; Unspecified Kidney or Urinary Problem; Urinary Retention; Urinary Tract Infection

  MAUDE report 22060923 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OBTRYX II SYSTEM - CURVED WAS IMPLANTED INTO THE PATIENT FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. SOMETIME AFTER IMPLANTATION, THE PATIENT WAS SEEN BY A UROLOGIST DUE TO TOTAL INCONTINENCE WITH FULL AND PAINFUL BLADDER AFTER A MAXIMUM OF TWO HOURS. SHE CAN NO LONGER RUN, BEND DOWN, OR JUMP WITHOUT EXPERIENCING URINARY LEAKAGE. WHENEVER SHE STRETCHES, TURNS, GET UP DURING NIGHT-TIME, IT LEAKS. SHE HAD SEVERAL AWAKENINGS DURING NIGHT BECAUSE OF BLADDER PAIN, AS IF IT WAS COMPLETELY FULL. CONSTANT BURNING SENSATION AND ITCHING WERE ALSO PRESENT, ALONG WITH URINARY TRACT INFECTIONS, SMALL PIMPLES ON THE CLITORIS AND TO THE VAGINAL ENTRANCE, AND VAGINAL ODOR. SHE ALSO NOTED PAIN IN HER RIGHT THIGH WHICH HAS BEEN EVALUATED AND DETERMINED NOT TO BE RELATED TO A VENOUS CONDITION. DURING SEXUAL INTERCOURSE, THE PATIENT EXPERIENCES SEVERE URINARY LOSS AND PAIN. THE UROLOGIST FIRST PROPOSED BOTOX INJECTIONS, THEN CHANGED THE RECOMMENDATION TO A TENSION FREE VAGINAL TAPE (TVT) IMPLANT. THE PATIENT REFUSED THE TVT DUE TO THE COMPLICATIONS ALREADY EXPERIENCED WITH THE TRANSOBTURATOR TAPE (TOT) AND THE DESIRE TO AVOID FURTHER RISKS. SINCE THEN, THE PATIENT HAS NOT

  Patient problems: Burning Sensation; Depression; Dyspareunia; Insufficient Information; Itching Sensation; Localized Skin Lesion; Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 22060498 ↗
• InjuryApr 29, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX II SYSTEM - HALO IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING PAIN AND PRESSURE IN THE BLADDER, PELVIS, AND VAGINA, DYSPAREUNIA, INFECTIONS, WORSENING URINARY PROBLEMS, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Discomfort; Dyspareunia; Dysuria; Hematuria; Insufficient Information; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 21928641 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING CYSTOCELE REPAIR SURGERY WITH THE OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM ON (B)(6) 2023, THE PATIENT DEVELOPED VAGINAL MESH EXPOSURE, ABDOMINAL AND PELVIC PAIN, DYSPAREUNIA, INFECTION, URINARY COMPLICATIONS, VAGINAL SCARRING, AND RECURRENCE OF INCONTINENCE AND PROLAPSE. ON (B)(6) 2023, THE PATIENT UNDERWENT A PARTIAL PELVIC MESH EXCISION. SUBSEQUENTLY, A SECOND PARTIAL PELVIC MESH EXCISION WAS PERFORMED BY A DIFFERENT SURGEON ON (B)(6) 2024, AT A DIFFERENT FACILITY.

  Patient problems: Abdominal Pain; Discomfort; Dyspareunia; Erosion; Incontinence; Insufficient Information; Pain; Prolapse; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21774380 ↗
• MalfunctionApr 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TRANSOBTURATOR TAPE PROCEDURE USING AN OBTRYX II SYSTEM - HALO DEVICE, THE MESH WAS BROKEN. THE EVENT IS UNCLEAR, AND BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THE EVENT DESCRIPTION MAY SUGGEST THAT THE MESH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763739 ↗
• InjuryOct 3, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PLACEMENT PROCEDURE USING AN OBTRYX II SYSTEM - HALO, WHEN THE PHYSICIAN WAS TRIMMING THE MESH OF THE SKIN, CUTTING THROUGH THE PLASTIC SHEATH AND MESH BEHIND THE BLUE DILATORS, SHE LOST THE GRIP ON THE SHEATH AND FELL INTO THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO DISSECT THE VAGINAL INCISION TO REACH UP THROUGH THE SLING PATHWAY TO GRAB HOLD OF THE PLASTIC SHEATH, BUT SHE COULD NOT FIND IT. THE PATIENT'S INCISIONS WERE THEN CLOSED UP, AND THE PATIENT STAYED IN THE HOSPITAL FOR MONITORING.

  Patient problems: Foreign Body In Patient

  MAUDE report 20364087 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY A MONTH AFTER AN OBTRYX II SYSTEM - HALO IMPLANT PROCEDURE, THE PATIENT WAS COMPLAINING OF POSTOPERATIVE PAIN NEAR THE URETHRA. ADDITIONALLY, THE PATIENT WAS EXPERIENCING INCONTINENCE AND PAIN BUT WAS DEEMED TO BE IN STABLE CONDITION. THERE WAS NO SPECIFIC TREATMENT PERFORMED DURING THE FOLLOW-UP OBSERVATION. AROUND TWO MONTHS LATER, THE PATIENT STILL PRESENTED PAIN THROUGH PALPATION. A NEW PROCEDURE WAS DISCUSSED. IT WAS SUGGESTED TO CONSIDER REMOVING THE MESH WHERE THE PAIN OCCURS AND HAVE A MESH RE-PLACEMENT THROUGH TENSION-FREE VAGINAL TAPE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain; Urinary Incontinence

  MAUDE report 20050825 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN OBTRYX II SYSTEM - HALO DEVICE ON AN UNSPECIFIED DATE. SOMETIME AFTER PLACEMENT, THE PATIENT STARTED PRESENTING SYSTEMIC SYMPTOMS AND WAS REFERRED TO THE DERMATOLOGY DEPARTMENT FOR AN ALLERGY TESTING. IT WAS NOTED THAT ALTHOUGH IT IS UNLIKELY THE SYMPTOMS MAY BE RELATED TO THE MESH, AN ALLERGY TESTING WAS REQUESTED TO RULE OUT THE POSSIBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19763667 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN OBTRYX II SYSTEM - HALO IMPLANTATION, THE PATIENT HAD EXPERIENCED INJURIES INCLUDING BUT NOT LIMITED TO: SEVERE VAGINAL PAIN, INCONTINENCE, PELVIC PAIN, MESH EROSION, VAGINAL MESH EXPOSURE, INABILITY TO PERFORM INTERCOURSE, FEVER, AND SURGERIES INCLUDING REMOVAL OF MESH. THE PATIENT ALSO EXPERIENCED PAIN AND SUFFERING, ECONOMIC DAMAGES, INCLUDING MEDICAL EXPENSES AND OUT OF POCKET EXPENSES.

  Patient problems: Dyspareunia; Erosion; Fever; Incontinence; Pain

  MAUDE report 19711590 ↗
• MalfunctionJun 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OBTRYX II SYSTEM - HALO IMPLANT PROCEDURE, THE SLEEVE DETACHED AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OBTRYX II SYSTEM - HALO DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575533 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A FEMALE MID-URETHRAL SLING PROCEDURE USING AN OBTRYX II SYSTEM - HALO DEVICE, THE ASSOCIATION WAS DETACHED FROM THE SLING. IT WAS NOTED THAT UPON OPENING THE DEVICE, THE ASSOCIATION LOOP WAS NOT PRESENT. ANOTHER OBTRYX SLING WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354927 ↗