Desara OneRecalls & reported problems across all models
Caldera Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 2 models of Desara One by Caldera Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between May 4, 2022 and Sep 29, 2026 — classified as 23 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Desara One problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- No Apparent Adverse Event7
- Insufficient Device Problem Information6
- Detachment of Device or Device Component3
- Appropriate Device Problem Term/Code Not Available2
- Premature Separation2
- Patient Device Interaction Problem1
Patient problems
- Urinary Retention7
- Erosion6
- No Clinical Signs, Symptoms or Conditions5
- Incontinence3
- Pain2
- Perforation2
- Urinary Incontinence2
- Dyspareunia1
Desara One models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Desara One CAL-DS2111Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling15 reports
- Desara One CAL-DS2113Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling14 reports
Recent Desara One adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941278 ↗MalfunctionSep 29, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941171 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER SALES REP, EROSIONS ARE HAPPENING AT THE MIDLINE. ALL PATIENTS ARE POST-MENOPAUSAL, ALL WERE PRESCRIBED VAGINAL ESTROGEN.
Patient problems: Erosion
MAUDE report 23467581 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER SALES REP, EROSIONS ARE HAPPENING AT THE MIDLINE. ALL PATIENTS ARE POST-MENOPAUSAL, ALL WERE PRESCRIBED VAGINAL ESTROGEN.
Patient problems: Erosion
MAUDE report 23467252 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER SALES REP, EROSIONS ARE HAPPENING AT THE MIDLINE. ALL PATIENTS ARE POST-MENOPAUSAL, ALL WERE PRESCRIBED VAGINAL ESTROGEN.
Patient problems: Erosion
MAUDE report 23467103 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER SALES REP, EROSIONS ARE HAPPENING AT THE MIDLINE. ALL PATIENTS ARE POST-MENOPAUSAL, ALL WERE PRESCRIBED VAGINAL ESTROGEN.
Patient problems: Erosion
MAUDE report 23420514 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE RN, ONE SIDE OF THE SLING WAS BROKEN AND UNUSABLE. THERE WAS NO INJURY TO THE PATIENT, AND A SECOND DEVICE WAS OPENED AND USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419975 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO SALES REPRESENTATIVE, THE DESARA ANCHOR DETACHED FROM THE MESH DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419256 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE SALES REPRESENTATIVE, THE DESARA ANCHOR DETACHED FROM ITS MESH DURING INSTALLATION. THE SURGEON USED ANOTHER ONE. NO HARM OR ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417853 ↗InjuryDec 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
SURGEON REPORTED PATIENTS PRESENTED WITH RETENTION POST-SURGERY. SURGEON INTERVENED WITH SLING REVISIONS AND REPORTS THAT PATIENTS ARE DOING WELL AFTER SLING REVISIONS.
Patient problems: Urinary Retention
MAUDE report 20854711 ↗InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER 522/CEC: URINARY RETENTION REQUIRING CATHETERIZATION WAS REPORTED. SUBJECT REQUIRED CATHETER FOR 7 DAYS FOLLOWING SURGERY. (SEPT 12-18, 2023) EVENT IS CONSIDERED RESOLVED. PER 522/CEC: SEPT 12, 2023 DESARA ONE WAS IMPLANTED WITHOUT INJURY. SUBJECT WAS DISCHARGED SAME DAY WITHOUT VOIDING AND WITH AN INDWELLING CATHETER. CEC ADJUDICATED THE AE IS POSSIBLY RELATED TO THE DEVICE, SLING PROCEDURE, AND/OR CONCOMITANT PROCEDURE. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR WHETHER THE AE IS DUE TO THE PRODUCT/DEVICE, SURGICAL TECHNIQUE, OR PATIENT SURGICAL HISTORY/ANATOMY.
Patient problems: Urinary Retention
MAUDE report 18369388 ↗InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER 522/CEC: (B)(6) 2023 - DESARA ONE IMPLANTED; CYSTOSCOPY CONFIRMED NO SURGICAL INJURY. SUBJECT DISCHARGED ON THE SAME DAY WITHOUT ISSUE. SUBJECT REPORTED DE NOVO DYSPAREUNIA BEGINNING MAY 31, 2023. EVENT IS CONSIDERED ONGOING. TREATMENT FOR THIS EVENT INCLUDED REVISION / RESURGERY ON (B)(6) 2023. SLING WAS REMOVED AND A NEW SLING PLACED. CEC ADJUDICATED THE AE IS POSSIBLY RELATED TO DEVICE AND/OR SLING PROCEDURE.
Patient problems: Dyspareunia
MAUDE report 18369387 ↗InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER 522 / CEC: ON (B)(6) 2023, DESARA ONE IMPLANTED WITH NO EVIDENCE OF INJURY. SUBJECT WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ISSUE. PER 522 / CEC: ACUTE RESPIRATORY FAILURE WITH HYPOXIA WAS REPORTED FROM ON (B)(6) 2023. THE IS CONSIDERED AN SAE DUE TO HOSPITALIZATION. CONCOMITANT MEDICATIONS HAVE NOT YET BEEN RECORDED IN EDC, THOUGH RECORDS WERE REQUESTED FOR REVIEW. CEC ADJUDICATED THE AE IS SEVERE, NOT RELATED TO DESARA ONE DEVICE, SLING IMPLANT PROCEDURE OR CONCOMITANT PROCEDURE. MOST LIKELY ANESTHETIC-RELATED.
Patient problems: Hypoxia; Respiratory Failure
MAUDE report 18369386 ↗InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER 522/CEC: (B)(6) 2023 - DESARA ONE IMPLANTED; CYSTOSCOPY CONFIRMED NO SURGICAL INJURY. SUBJECT DISCHARGED ON THE SAME DAY. VOIDING WAS NOT POSSIBLE, AND SUBJECT WAS DISCHARGED WITH INSTRUCTIONS TO SELF-CATHETERIZE (WHICH SHE DID FOR 8 DAYS). URINARY RETENTION REQUIRING CATHETERIZATION REPORTED FROM JUNE 1 - OCT. 10, 2023. EVENT WAS INITIALLY TREATED WITH UROLOGS AND SELF-CATHETERIZING, THEN SUBJECT UNDERWENT REVISION / RESURGERY, "SLING REVISION FOR VOIDING DYSFUNCTION OR RETENTION; CUT SLING" ON (B)(6) 2023. EVENT IS NOW RESOLVED.
Patient problems: Urinary Retention
MAUDE report 18369385 ↗InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGEON REPORTED 2 CASES OF EROSION WITH DESRA ONE PRODUCT OCCURING APPROXIMATELY ONE YEAR AGO. PATIENTS ARE IN GOOD CONDITION AND WERE GIVEN ESTROGEN CREAM TO HELP WITH THE ISSUE. BOTH PATIENTS WERE POST-MENOPAUSAL AND NON-SMOKERS.
Patient problems: Erosion
MAUDE report 16964365 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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