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Desara Blue OV CAL-DSO1BOVRecalls & reported problems

Caldera Medical, Inc. · Desara® Blue OV sling system for female stress urinary incontinence · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00890594000704), received between Jul 17, 2019 and Mar 6, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Defective Component1
  • Insufficient Device Problem Information1
  • Material Split, Cut or Torn1
  • No Apparent Adverse Event1

Patient problems

  • Insufficient Information1
  • Micturition Urgency1
  • No Clinical Signs, Symptoms or Conditions1
  • Obstruction/Occlusion1
  • Urinary Retention1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2023Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn

    DESARA BLUE TORE DURING MID-URETHRAL SLING ON (B)(6) 2022. PER SURGEON, MESH "FELT THAT IT COULD HAVE BEEN CAUGHT ON SOMETHING. PATIENT BMI IS 43 AND HAD NO HISTORY OF RETROPUBIC PROCEDURES".

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16486523 ↗
  • 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 MODERATE TO MILD URGENCY. CEC ADJUDICATED NOT RELATED TO DEVICE/PRODUCT.

    Patient problems: Micturition Urgency

    MAUDE report 16486500 ↗
  • InjuryJul 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    ON 06/26/19 SALES REP REPORTS: "ONE OF MY SURGEONS (DR. (B)(6) AT THE (B)(6) CLINIC) TOLD ME ABOUT A FEW ISSUES THIS MORNING THAT HAVE CAUSED HER TO SWITCH BACK TO ETHICON. SHE HAS BEEN USING DESARA BLUE AND DESARA BLUE TV FOR ABOUT 4 MONTHS NOW. SHE HAD AN "OBSTRUCTION" WITH TWO PATIENTS USING THE TOT APPROACH. SHE ALSO HAD TO PUT A THIRD PATIENT BACK UNDER ANESTHESIA BECAUSE OF PELVIC PAIN AFTER SHE IMPLANTED OUR SLING. SHE MENTIONED THAT SHE WENT BACK IN AND IT LOOKED LIKE IT HAD COMPLETELY CURLED INTO ITSELF. IT SOUNDS TO ME LIKE SHE'S TENSIONING IT TOO TIGHTLY, WHICH MAKES SENSE COMING FROM A PRE-ETHICON USER. I PREPPED HER ON TENSIONING BEFORE SHE STARTED USING CALDERA, BUT MAYBE SHE'S STILL TENSIONING TOO TIGHT, CAUSING IT TO CURL. SHE ALSO MADE A COMMENT IN THE PAST ABOUT HOW OUR MESH LOOKS LIKE IT WAS NOT HEAT-TREATED IN THE MIDDLE ON THE TOP AND BOTTOM EDGE BECAUSE THE MESH LOOKED FRAYED. THIS IS ALL OF THE INFORMATION I WAS ABLE TO GET, AS SHE WAS IN THE MIDDLE OF A HYSTERECTOMY WHEN SHE TOLD ME ABOUT THESE EXPERIENCES." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SALES REP AND SURGEON INCLUDING DETAILS, TREATMENT, AND LOT NUMBER ASSOCIATED WITH ISSUE. ON 07/09/2019,

    Patient problems: Obstruction/Occlusion; Urinary Retention

    MAUDE report 8798094 ↗

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Sources and updates

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