Desara One CAL-DS2111Recalls & reported problems
Caldera Medical, Inc. · Single Incision Sling System (1/box) · Class 2 · Implant
All models of Desara One (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00890594000957), received between May 4, 2022 and Sep 29, 2026 — classified as 10 injuries, 5 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 Problem8
- Detachment of Device or Device Component2
- Insufficient Device Problem Information2
- No Apparent Adverse Event2
- Premature Separation2
- Patient Device Interaction Problem1
Patient problems
- Erosion5
- No Clinical Signs, Symptoms or Conditions4
- Urinary Retention4
- Perforation1
- Urinary Tract Infection1
Recent adverse event reports
The 15 most recent of 15 reports, 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 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 ↗MalfunctionMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A DESARA ONE SLING IMPLANTED ON (B)(6) 2023. PATIENT EXPIERENCED RETENTION ISSUES POST OPERATIVELY. PATIENT WENT BACK TO THE HOSPITAL WHERE THE SURGEON REMOVED THE SLING. SLING WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR WHETHER THE AE IS RELATED TO PRODUCT/DEVICE, PATIENT ANATOMY, MEDICAL HISTORY, OR SURGICAL TECHNIQUE.
Patient problems: Urinary Retention
MAUDE report 16920035 ↗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, SUBJECT WAS UNABLE TO URINATE POST-OP AND SENT HOME WITH CATHETER. SUBJECT RETURNED TO OFFICE FOR FOLEY REMOVAL AND VOIDING TRAIL, AND WAS CONFIRMED THAT ISSUE HAD RESOLVED. CEC ADJUDICATED THAT EVENT WAS POSSIBLY RELATED TO DEVICE/PRODUCT.
Patient problems: Urinary Retention
MAUDE report 16486489 ↗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; UTI FROM (B)(6) 2022. EVENT WAS TREATED WITH NITROFURANTOIN AND IS CONSIDERED RESOLVED. CEC ADJUDICATED EVENT WAS NOT RELATED TO DEVICE/PRODUCT. UTI (B)(6) 2022. EVENT WAS TREATED WITH NITROFURANTOIN AND IS CONSIDERED RESOLVED. CEC ADJUDICATED EVENT WAS NOT RELATED TO DEVICE/PRODUCT.
Patient problems: Urinary Tract Infection
MAUDE report 16486488 ↗InjuryMay 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS EXPERIENCING PAIN FROM A DESARA ONE IMPLANT AND HAD THE SLING REMOVED.
Patient problems: Erosion
MAUDE report 14275093 ↗InjuryMay 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
DURING THE PROCEDURE, THE PHYSICIAN WAS DOING THE FINAL TENSIONING ON THE IMPLANT WHEN HE NOTICED ONE SIDE HAD PERFORATED THE BLADDER. THE PHYSICIAN PROCEEDED TO READJUST THE OTHER SIDE WHEN HE NOTICE THE BLADDER WAS PERFORATED AS WELL. THE PHYSICIAN STOPPED THE PROCEDURE, DID NOT IMPLANT THE SLING, PLACED A CATHETER IN THE PATIENT. PATIENT WAS SENT HOME AND WILL RETURN SOME TIME LATER FOR THE OPERATION
Patient problems: Perforation
MAUDE report 14275001 ↗
Other Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling devices
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- Solyx™ Blue M0068507010Boston Scientific Corporation · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling55 reports
- Desara One CAL-DS2113Caldera Medical, Inc. · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling14 reports
- Needleless Sling NL-01Desarrollo E Investigacion Medica Aragonesa Sl · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling1 report
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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