Desara One CAL-DS2113Recalls & reported problems
Caldera Medical, Inc. · Single Incision Sling System (3/box) · Class 2 · Implant
All models of Desara One (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00890594000971), received between Nov 7, 2022 and Oct 29, 2025 — classified as 13 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 Problem12
- No Apparent Adverse Event5
- Insufficient Device Problem Information4
- Appropriate Device Problem Term/Code Not Available2
- Detachment of Device or Device Component1
Patient problems
- Incontinence3
- Urinary Retention3
- Pain2
- Urinary Incontinence2
- Dyspareunia1
- Erosion1
- Genital Bleeding1
- Hypoxia1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
PER (B)(4) STUDY, PATIENT REPORTED; PERSISTENT STRESS INCONTINENCE ON (B)(6) 2022. POP-Q, UA, AND VITALS ASSESSED. EVENT WAS LISTED AS RECOVERING/RESOLVING FOLLOWING INTERVENTION (OXYBUTYNIN) WORSENING URGE INCONTINENCE ON (B)(6) 2022. POP-Q, UA, AND VITALS ASSESSED. EVENT WAS LISTED AS RECOVERING/RESOLVING FOLLOWING INTERVENTION (OXYBUTYNIN) CAUSE OF EVENT IS UNDECIDED, CEC REVIEWING RECORDS.
Patient problems: Incontinence; Urinary Incontinence
MAUDE report 16486532 ↗InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
PER 522 STUDY, IT WAS REPORTED THAT THE PATIENT WAS EXPIERENCING HIP PAIN ON (B)(6), 2022 FOLLOWING THE PROCEDURE. EVENT RECOVERED WITH GENTLY HIP STRETCHING AS OF (B)(6), 2022. CEC ADJUDICATED THE EVENT WAS NOT RELATED TO DEVICE/PRODUCT BUT RELATED TO THE SLING PROCEDURE.
Patient problems: Pain
MAUDE report 16486530 ↗InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
PER 522 STUDY, PATIENT WAS UNABLE TO VOID POST-SURGERY ON (B)(6) 2022 AND WAS SENT HOME WITH A CATHETER THAT WAS USED FOR 5 DAYS POST-OP. PATIENT RETURNED 5 DAYS AFTER PROCEDURE AND IT WAS CONFIRMED THAT THE EVENT WAS RESOLVED AT THAT TIME. CEC ADJUDICATED THAT THE EVENT WAS POSSIBLY RELATED TO DEVICE/PRODUCT AND/OR PROCEDURE. POST-OP URINARY RETENTION WAS REPORTED ON (B)(6), 2022. SUBJECT SELF-CATHERTERIZED DURING THIS TIME AND EVENT IS CONSIDERED RESOLVED. CEC ADJUDICATED EVENT IS POSSIBLY RELATED TO DEVICE/PRODUCT AND/OR SLING PROCEDURE.
Patient problems: Urinary Retention
MAUDE report 16486524 ↗InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
PER 522 STUDY, PATIENT HAD URINARY RETENTION REQUIRING CATHETERIZATION FOR 3 DAYS POST-OP. AFTER 3 DAYS THE EVENT WAS CONSIDERED RESOLVED. CEC ADJUDICATED THE EVENT WAS POSSIBLY RELATED TO DEVICE/PRODUCT AND/OR PROCEDURE.
Patient problems: Urinary Retention
MAUDE report 16486498 ↗InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
PER (B)(4) STUDY, IT WAS REPORTED; DE NOVO URGE INCONTINENCE ON (B)(6) 2022. URINALYSIS AND URINE CULTURE WERE OBTAINED, NO TREATMENT REQUIRED. CEC ADJUDICATED EVENT IS POSSIBLY RELATED TO DEVICE/PRODUCT.
Patient problems: Incontinence; Urinary Incontinence
MAUDE report 16486491 ↗InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON (B)(6) 2022: DESARA ONE SIS IMPLANTED, CYSTOSCOPY CONFIRMED NO SURGICAL INJURY. SUBJECT DISCHARGED ON THE FOLLOWING DAY WITHOUT ISSUE. SUBJECT REPORTING DE NOVO URGE INCONTINENCE AS OF ON (B)(6) 2022. EVENT IS CURRENTLY ONGOING. URINALYSIS AND URINE CULTURE HAVE BEEN OBTAINED. AE WAS DETERMINED BY INVESTIGATOR TO BE: MILD, POSSIBLY RELATED TO DESARA ONE DEVICE, POSSIBLY TO SLING IMPLANT PROCEDURE, NOT RELATED TO CONCOMITANT PROCEDURE.
Patient problems: Incontinence
MAUDE report 15745702 ↗InjuryNov 7, 2022Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2022: DESARA ONE SIS IMPLANTED. CYSTOSCOPY CONFIRMED MESH IN BLADDER. REPAIR OF URETHRA AND PLACEMENT OF SLING WAS REQUIRED (REVISION/RESURGERY) TO ADDRESS PERFORATION OF URETHRA (INJURY BY SURGEON NOT WITH TROCAR) AT TIME OF SLING IMPLANT PROCEDURE. SYMPTOMS OF MESH EXPOSURE CONFIRMED TO BE RESOLVED AT TIME OF REVISION. DATES OF URETHRA PERFORATION (RIGHT LATERAL): ON (B)(6) 2022 AE WAS DETERMINED BY INVESTIGATOR TO BE: MODERATE, NOT RELATED TO DESARA ONE DEVICE, DEFINITELY TO SLING IMPLANT PROCEDURE, NOT RELATED TO CONCOMITANT PROCEDURE.
Patient problems: Perforation; Uterine Perforation
MAUDE report 15745359 ↗InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON (B)(6) 2022: DESARA ONE SIS IMPLANTED, CYSTOSCOPY CONFIRMED NO SURGICAL INJURY. SUBJECT DISCHARGED ON SAME DAY WITHOUT ISSUE. SUBJECT REPORTED EVENT OF TAILBONE PAIN ON (B)(6) 2022 (SAME DAY AS PROCEDURE). PAIN WAS TREATED WITH TYLENOL AND ALEVE. EVENT IS CONSIDERED RESOLVED WITHOUT SEQUELAE. AE WAS DETERMINED BY INVESTIGATOR TO BE: MODERATE, NOT RELATED TO DESARA ONE DEVICE, NOT TO SLING IMPLANT PROCEDURE, DEFINITELY RELATED TO CONCOMITANT PROCEDURE: PELVIC ORGAN PROLAPSE REPAIR.
Patient problems: Pain
MAUDE report 15745303 ↗InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2022: DESARA ONE SIS IMPLANTED, CYSTOSCOPY CONFIRMED NO SURGICAL INJURY. SUBJECT DISCHARGED ON FOLLOWING DAY WITH CATHETER THAT WAS USED FOR 5 DAYS POST-OP. EVENT REPORTED AS GRANULATION TISSUE AT APEX CAUSING BLEEDING WITH AN UNKNOWN START DATE IS NOTED TO HAVE RESOLVED WITH MINOR/INTRA-OFFICE SURGICAL INTERVENTION ON (B)(6) 2022. AE WAS DETERMINED BY INVESTIGATOR TO BE: MODERATE; NOT RELATED TO DESARA ONE DEVICE; NOT TO SLING IMPLANT PROCEDURE; DEFINITELY RELATED TO CONCOMITANT PROCEDURE: HYSTERECTOMY.
Patient problems: Genital Bleeding
MAUDE report 15745063 ↗
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- Desara One CAL-DS2111Caldera Medical, Inc. · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling15 reports
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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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