Remeex System (for Female Urinary Incontinence) SREM-01Recalls & reported problems
Desarrollo E Investigacion Medica Aragonesa Sl · Class 2 · Implant
Data updated Oct 18, 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 08437007606027), received between May 15, 2025 and May 15, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abscess1
- Fever1
- Inflammation1
- Medical device site infection1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A REMEEX SYSTEM DEVICE IMPLANTED IN 2017. IN (B)(6) 2025, THE PATIENT REPORTED PAIN AND INFLAMMATION OF THE SUPRAPUBIC IMPLANT COMPONENT, WITH AN ACCOMPANYING FEVER FOR TWO DAYS. THE PATIENT PRESENTED BIOLOGICAL INFLAMMATORY SYNDROME WITH A SCAN CONFIRMING INFLAMMATION OVER THE IMPLANTED COMPONENT. PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY AND PARTIAL EXPLANTATION OF THE DEVICE (SUPRAPUBIC IMPLANT COMPONENT WHICH ALLOWS FOR CONTINUOUS TENSION ADJUSTMENT OF THE SLING).
Patient problems: Abscess; Fever; Inflammation; Medical device site infection; Pain
MAUDE report 22029284 ↗
Other Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator devices
- GYNECARE TVT 810081Ethicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator629 reports
- GYNECARE TVT EXACT TVTRLEthicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator457 reports
- Advantage Fit™ System M0068502110Boston Scientific Corporation · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator451 reports
- GYNECARE TVT 810081LEthicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator371 reports
- GYNECARE TVT 810041BEthicon Sàrl · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator362 reports
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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