Desara CAL-DS01 (UDI 00890594000896)Recalls & reported problems
Caldera Medical, Inc. · Desara sling system for female stress urinary incontinence. · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00890594000896), received between Nov 9, 2023 and Nov 9, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Erosion2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
REPORTED CASE OF EROSION WITH DESARA CLEAR PRODUCT. IMPLANTED ON (B)(6) 2022. UNCLEAR WHETHER THE EVENT IS DUE TO PRODUCT DEVICE, PATIENT MEDICAL HISTORY, OR SURGICAL TECHNIQUE.
Patient problems: Erosion
MAUDE report 18103826 ↗InjuryNov 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
REPORTED EROSION WITH DESARA CLEAR PRODUCT. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR WHETHER THE EVENT IS DUE TO PRODUCT DEVICE, PATIENT MEDICAL HISTORY, OR SURGICAL TECHNIQUE.
Patient problems: Erosion
MAUDE report 18103825 ↗
Other Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator devices
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.