Conservia™ M0068504210Recalls & reported problems
Boston Scientific Corporation · Transobturator/Suprapubic Mid-Urethral Sling · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729856030), received between Mar 3, 2022 and Mar 3, 2022 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Constipation1
- Dysuria1
- Pain1
- Urinary Retention1
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 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 A CONSERVIA SLING DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2017. THE PATIENT HAD TO HAVE A HYSTERECTOMY AND WAS ADVISED TO UNDERGO PLACEMENT OF SMALL TRANSOBTURATOR TAPE FOR SMALL URINARY LEAKS. AFTER THE IMPLANTATION, FROM (B)(6), 2017, THE PATIENT HAD EXPERIENCED SOME POSTOPERATIVE COMPLICATIONS. THE MESH HAD TO BE SEVERED DUE TO URINARY RETENTION. SHE HAD SUBSEQUENT URINARY TRACT INFECTION, PAIN IN THE URETHRA, VAGINAL AREA, BUTTOCKS, THIGH AND A TERMINAL CONSTIPATION. CURRENTLY, THE PATIENT STILL HAS DIFFICULTY IN URINATING AND URINARY TRACT INFECTIONS. PAIN IS ALSO PRESENT IN THE VAGINA, URETHRA, BUTTOCKS AND THIGHS, ESPECIALLY WHEN SITTING AND SQUATTING, AND IN THE LOWER BACK.
Patient problems: Constipation; Dysuria; Pain; Urinary Retention; Urinary Tract Infection
MAUDE report 13664846 ↗
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- Obtryx™ System - Halo M0068505000Boston Scientific Corporation · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator288 reports
- Aris 93-4400Coloplast A/S · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator215 reports
- Align® TO Trans-Obturator Urethral Support System - Halo BRD500HLC. R. Bard, Inc. · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator213 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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