Desara Blue Short Suture Sling CAL-DS01BSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00890594000735), received between Jun 21, 2019 and Jun 4, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Separation

  CALDERA WAS NOTIFIED THAT TRIHEALTH (BETHESDA NORTH HOSPITAL) REPORTED AN ISSUE WITH A DESARA BLUE SS SLING, LOT R06068. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 INDICATED THAT, WHEN THE SURGEON WAS PUTTING THE TROCAR INTO THE LOOP, THE LOOP STITCHING BROKE. NO PATIENT INJURY, PROCEDURE IMPACT, DEVICE RETURN STATUS, SERIAL NUMBER, UDI, IMPLANT INFORMATION, TREATMENT, OR PATIENT OUTCOME WAS PROVIDED AT THE TIME OF THIS REPORT. THE FACILITY REQUESTED A REPLACEMENT PRODUCT. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25402521 ↗
• MalfunctionMay 28, 2026Break; Material Integrity Problem

  DURING PLACEMENT OF A DESARA BLUE SHORT SUTURE SLING (CAL-DS01BS, LOT Q08025), THE SUTURE BROKE INTRAOPERATIVELY. THE SURGEON PLACED A SECOND SLING TO COMPLETE THE PROCEDURE. NO PATIENT INJURY RESULTED. REPORTED BY (B)(6) ON (B)(6) 2026, ORIGINATING FROM DR. (B)(6), (B)(6) MEDICAL CENTER, (B)(6). REPLACEMENT REQUESTED; RETURN OF FAILED DEVICE (LOT Q08025) FOR EVALUATION TO BE REQUESTED. INVESTIGATION ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25324484 ↗
• MalfunctionMar 25, 2024

  THE STRING BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967478 ↗
• 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).- 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 8723779 ↗