Desara Blue TVez 3.0 CAL-DS01BTV30 (UDI 00890594000087)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
- 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 00890594000087), received between Oct 29, 2025 and Oct 29, 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
- Hyperplasia1
- Hypersensitivity/Allergic reaction1
- Pain1
- Sexual Dysfunction1
- Skin Discoloration1
- Swelling/ Edema1
- Unspecified Nervous System Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FDA (FOOD AND DRUG ADMINISTRATION) SENT A MEDICAL DEVICE REPORT UNDER MW5162638. PT HISTORY OF RENAL CONGENITAL DEFECTS. TOLD MUS WAS SAFE AND GOLD STANDARD. SURGEON RECOMMENDED MUS AFTER POP REPAIR, STATING URETHRA WAS "KINKED" AND WOULD NEED SUPPORT AFTER POP (PELVIC ORGAN PROLAPSE) REPAIR. PT HAD THIN VAG TISSUES. SURGEON PLACED MUS A LITTLE DIFFERENTLY (PER SURGEON). PT COMPLAINED IN POST-OP RECOVERY OF UNUSUAL SEVERE PAIN, SWELLING, CLOTS, BLEEDING, AND SEVERE URETHRAL SWELLING. PT DISMISSED AND TOLD ALL NORMAL. PT REPORTED SEVERE TISSUE AND NERVE PAIN, CLINICAL SWELLING, MESH PALPABLE W/ INTERNAL EXAM, INABILITY TO SIT, FOR MONTHS FOLLOWING MUS AND POP SX. PT ADVOCATED FOR HELP COMPLAINING OF CONT. POST SURGICAL PAIN, INABILITY TO SIT, URETHRAL/CLITORAL PAIN. PT DISMISSED. PT OUTSOURCED TO ANOTHER STATE FOR MEDICAL CARE, AND TO HAVE MESH REMOVED. PT ALLERGIC TO MESH AND HAD DX MESH COMPLICATIONS. PT SUFFERED SEVERE PAIN, SWELLING, HYPERPLASIA, NERVE PAIN, CLINICAL SWELLING AND REDNESS. PT DEVELOPED SEVERE INTERNAL BLEEDING DURING MESH REMOVAL SX. PT NEEDED RE-HOSPITALIZATION FOR BLOOD TRANSFUSION FROM MESH REMOVAL. PT SUFFERS WITH SCAR TISSUE AND ADHESIONS FROM MESH AND M
Patient problems: Hyperplasia; Hypersensitivity/Allergic reaction; Pain; Sexual Dysfunction; Skin Discoloration; Swelling/ Edema; Unspecified Nervous System Problem
MAUDE report 23416527 ↗
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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