Desara Blue TVez 3.0 CAL-DS01BTV30 (UDI 00890594000124)Recalls & reported problems
Caldera Medical, Inc. · Desara Blue TVez 3.0mm 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
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00890594000124), received between Jul 29, 2022 and Oct 28, 2025 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- Material Separation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Urinary Retention2
- Perforation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE SURGEON ADVANCED THE SLING THROUGH THE PATIENT AS USUAL, AND THE TROCAR CAME THROUGH JUST AT THE END OF THE BLUE DILATOR TUBE. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL; ANOTHER SLING WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406039 ↗MalfunctionDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PRIOR TO A SURGICAL PROCEDURE TO IMPLANT A DESARA MESH IN A PATIENT, THE INSTRUMENT WIRE COMPONENT DETACHED FROM ITS HANDLE. THE WIRE BROKE LOOSE, RESULTING IN THE WIRE SPINNING FREELY WITHIN THE HANDLE AND EVENTUALLY COMING OUT COMPLETELY FROM THE HANDLE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WERE REPORTED. BASED ON THE COMPLAINT INFORMATION PROVIDED, IT IS UNCONCLUSIVE IF THE EVENT IS RELATED TO THE DEVICE, SURGICAL APPROACH, SURGEON EXPERIENCE, AND/OR PATIENT ANATOMY. DEVICE HISTORY RECORDS WERE REVIEWED AND DEVICE MET ALL ACCEPTANCE CRITERIA. THIS REPORT IS FILED PURSUANT TO 21 CFR 803 AND ALL INFORMATION CONTAINED WITHIN THIS REPORT IS SUBJECT TO THE DETAILS PROVIDED BY THE REPORTER. ANY SUBSEQUENT INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854855 ↗InjuryAug 22, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT HAD RETENTION USING DESARA TVEZ3.0, VOIDING 0 ML.
Patient problems: Urinary Retention
MAUDE report 17600519 ↗InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
SURGEON HAS 2 CASES OF RETENTION WITH DESARA TVEZ3.0 WITH PATIENTS UNABLE TO VOID POST-OP. EXACT DATE OF PROCEDURE FOR EACH PATIENT IS UNKNOWN. BASED ON INFORMATION PROVIDED, IT IS UNCLEAR WETHER THE EVENT IS RELATED TO THE PRODUCT, PATIENT MEDICAL HISTORY, OR SURGICAL TECHNIQUE.
Patient problems: Urinary Retention
MAUDE report 16964363 ↗MalfunctionMay 19, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
DURING A PROCEDURE USING DESARA TVEZ3.0, THE WIRE CAME LOOSE AS THE SURGEON WAS PASSING THROUGH THE ANATOMICAL PATH. THERE WERE NO INJURIES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16964362 ↗InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem
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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