Desara Blue TVez 2.7 CAL-DS01BTV27Recalls & reported problems
Caldera Medical, Inc. · Desara Blue TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00890594000193), received between May 4, 2022 and May 4, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Device problems
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
DURING A TRIAL OF DESARA TVEZ 2.7, THE PHYSICIAN ENCOUTERED SOME RESISTANCE IN THE PATIENTS ABDOMEN. HE RETRACTED THE INSTRUMENT SLIGHTLY IN ORDER TO MAKE A PUNCTURE INCISION AND THEN REPASSED THE INSTRUMENT. AT THIS POINT, THE SURGEON REALIZED THAT THE DILATOR TUBE WAS NO LONGER ON THE TROCAR. UPON WIDTHDRAWING THE INSTRUMENT, IT WAS IDENTIFIED THAT THE TROCAR HAD BROKEN THROUGH AND DAMAGED THE DILATOR TUBE. THE PROCEDURE WAS COMPLETED WITH OUR DESARA BLUE TV DEVICE WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14275013 ↗
Other Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator devices
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- 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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