Desara Blue CAL-DS01BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00890594000674), received between Jun 21, 2019 and Dec 20, 2023 — classified as 7 injuries, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER 522/CEC : (B)(6) 2022 - DESARA BLUE IMPLANTED, CYSTOSCOPY CONFIRMED NORMAL/NO SURGICAL INJURY. SUBJECT DISCHARGED (B)(6) 2022 WITHOUT ISSUE. BACTERIAL VAGINOSIS REPORTED WIH AN ONSET DATE OF AUG 2, 2023. EVENT WAS CONSIDERED ONGOING, THOUGH NOTED TO BE RECOVERING/RESOLVING. EVENT IS BEING TREATDWITH FLAGYL 500MD BID. PATIENT FOLLOW-UP CONFIRMED THE AE IS NOT ATTRIBUTED TO MESH EROSION.

  Patient problems: Bacterial Infection

  MAUDE report 18369389 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESARA BLUE WAS IMPLANTED ON (B)(6)2022, AND ON (B)(6)2022, PATIENT REPORTED POSTCOITAL BLEEDING AND DEEP PAIN WITH INTERCOURSE. EVENT IS ONGOING AND HAS BEEN TREATED WITH (NON-SPECIFIC) MEDICAL INTERVENTION. SUBJECT IS PART OF 522 STUDY, AND CEC HAS ADJUDICATED AE IS NOT RELATED TO THE DEVICE AND IS POSSIBLY RELATED TO THE PROCEDURE AND/OR CONCOMITANT PROCEDURE.

  Patient problems: Genital Bleeding; Intermenstrual Bleeding; Pain

  MAUDE report 16964366 ↗
• 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

  AS A RESULT OF (B)(4) STUDY, PATIENT REPORTED; DYSURIA ON (B)(6) 2022, TREATED WITH MACROBID AND IS CONSIDERED RESOLVED. CEC ADJUDICATED NOT RELATED TO DEVICE/PRODUCT. MENOPAUSAL VAGINAL DRYNESS ON (B)(6) 2022, CEC ADJUDICATED NOT RELATED TO DEVICE/PRODUCT. DRIBBLING ON (B)(6) 2022, CEC ADJUDICATED POSSIBLY RELATED TO DEVICE/PRODUCT, NO FURTHER INFORMATION PROVIDED.

  Patient problems: Dysuria

  MAUDE report 16487049 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS PART OF (B)(4) STUDY, PATIENT REPORTED; UTI ON (B)(6) 2022, EVENT TREATED WITH AZO (PRN, MACROBID, AND LEVAQUIN, CEC ADJUDICATED NOT RELATED TO PRODUCT. WORSENED PROLASPE ON (B)(6) 2022 AND IS CONSIDERED ONGOING. CEC ADJUDICATED NOT RELATED TO PRODUCT. DYSURIA ON DECEMBER (B)(6) 2022, EVENT TREATED WITH MACROBID. CEC REQUESTED MORE INFORMATION.

  Patient problems: Dysuria; Urinary Tract Infection

  MAUDE report 16486538 ↗
• 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; URINARY RETENTION REQUIRING CATHETERIZATION ON (B)(6) 2022. EVENT TREATED BY SUBJECT SELF-CATHETERIZING, AND PYRIDIUM AND BACTRIM. EVENT IS CONSIDERED RESOLVED. CEC ADJUDICATED EVENT POSSIBLY RELATED TO DEVICE/PRODUCT AND/OR PROCEDURE. URINARY TRACT INFECTION (B)(6) 2022, EVENT TREATED WITH CIPRO AND IS CONSIDERED RESOLVED. CEC ADJUDICATED NOT RELATED TO DEVICE/PRODUCT. WORSENING URGENCY ON (B)(6) 2022. EVENT HAS BEEN TREATED WITH OXYBUTYNIN CR AND MYRBETRIQ. CEC ADJUDICATED EVENT IS POSSIBLY RELATED TO DEVICE/PRODUCT. DYSURIA ON (B)(6) 2022, REQUIRED MEDICAL INTERVENTION AND IS RESOLVING. CEC ADJUDICATED EVENT IS POSSIBLY RELATED TO DEVICE/PRODUCT.

  Patient problems: Dysuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 16486487 ↗
• MalfunctionJul 29, 2022Material Deformation

  "THEY WERE DOING 02-019 SLING PLACEMENT. SHE SAID THEY HAD TO USE TWO DEVICES BECAUSE THE FIRST DEVICE "CURLED IN THE SUB-URETHRAL AREA."

  Patient problems: Insufficient Information

  MAUDE report 15135775 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem

  AFTER SURGEON PERFORATED THE BLADDER, IT WAS DETERMINED THE SLING WOULD NOT BE IMPLANTED AND A CATHETER WOULD BE LEFT IN OVERNIGHT. NO OTHER TREATMENT WAS BELIEVED TO BE NEEDED. DURING THE PROCEDURE A CAL-TV32 WAS USED WITH A RETROPUBIC TRANSVAGINAL APPROACH.

  Patient problems: Internal Organ Perforation

  MAUDE report 14274623 ↗
• InjuryJun 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTS THE FOLLOWING COMPLAINT FROM DR. (B)(6) REGARDING TENSIONING ISSUES WITH DESARA SLINGS DUE TO A LACK OF "CENTER TAB." SURGEON STATES THAT THE PAST TWO PATIENTS SHE IMPLANTED WITH DESARA HAD RETENTION ISSUES AND COULD NOT VOID FOR SEVERAL DAYS POST OP. "DR. (B)(6) AT (B)(6) HOSPITAL, (B)(6). BOSTON OBTRYX USER - OUTSIDE IN APPROACH. DR. (B)(6) HAS TRIALED DESARA BLUE FOR 3 CASES AND DESARA SS FOR 2 CASES AND HAD A FEW ISSUES BUT BIGGEST ONE BEING THAT THERE IS NO CENTER TAB FOR HER TO USE FOR TENSIONING. SHE SAID THE PAST 2 PATIENTS SHE IMPLANTED WITH DESARA HAD "RETENTION ISSUES AND COULD NOT VOID FOR SEVERAL DAYS POST OP". AGAIN, NO CENTER TAB OR TENSIONING DEVICE IS THE BIG HOT BUTTON WITH THIS DOCTOR." PER SALES REP "HERE ARE THE SLINGS USED IN THE LAST TWO PATIENTS BY DR. (B)(6) - DESARA BLUE, LOT # H09002, DESARA BLUE SS, LOT # J07001." A PMS REPORT HAS BEEN FILED TO CAPTURE THE ISSUE OF A LACK OF CENTER TAB. THE ISSUE OF POST-OP URINARY RETENTION IS CAPTURED IN THIS PRODUCT COMPLAINT AND ACCOMPANYING COMPLAINT (B)(4).

  Patient problems: Urinary Retention

  MAUDE report 8724953 ↗