Desara Blue TV CAL-DS01BTVRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00890594000858), received between Jun 21, 2019 and Jul 23, 2025 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Material Integrity Problem; Material Integrity Problem

  SURGEON REPORTED WHILE PULLING THE DILATOR TUBES UP ABOVE THE PUBIC BONE, THE TUBE DETACHED FROM THE PLASTIC SHEATH.

  Patient problems: Failure of Implant

  MAUDE report 22583288 ↗
• MalfunctionJul 21, 2025Mechanical Problem; Mechanical Problem

  THE PATIENT WITH A COMPLEX MEDICAL HISTORY INCLUDING A SINGLE KIDNEY, ABDOMINAL ADHESIONS, SACROCOLPOPEXY, AND PELVIC ORGAN PROLAPSE, UNDERWENT BOTH ROBOTIC-ASSISTED AND TRADITIONAL SURGERY. AT THE SIX-WEEK POST-OP FOLLOW-UP, RECOVERY APPEARED NORMAL. HOWEVER, BY THE TEN-WEEK MARK, THE PATIENT REPORTED LOCALIZED PAIN AT THE LEFT SUPRA-PUBIC INCISION SITE, WHERE 3/4 TO 1 INCH CLEAR PLASTIC TUBE-LIKE OBJECT EMERGED, POSSIBLY FROM AN INFECTION. THE PATIENT INITIALLY IDENTIFIED THE PAIN AS ORIGINATING FROM THE SUPRA-PUBIC INCISION BUT LATER REVISED THE ASSESMENT, ATTRIBUTING IT TO A ROBOTIC INCISION SITE. THE SURGEON AND ONE CLOSELY MONITORED ATTENDING WERE PRESENT AT THE CASE. PHOTOGRAPHS SHOWED THE INCISION AS CLOSED AND HEALING. DR. LIND RECOMMENDED IDENTIFYING ALL 50 COMPONENTS USED IN THE ROBOTIC SYSTEM, NOTING THE EXPELLED OBJECT RESEMBLED A TIP PROTECTOR USED ROBOTIC-ASSISTED SURGERY SIMILAR TO CALDERA MEDICAL'S HEAT-SHRINK TUBING. DESPITE THE COMPLICATION, THE OVERALL SURGICAL OUTCOME WAS POSITIVE.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 22561859 ↗
• InjuryMay 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DOCTOR REPORTED THAT THE PATIENT REQUIRED EXPLANT OF DESARA BLUE TV SLING SIX MONTHS POST-OP DUE TO PAIN. THE SLING WAS IMPLANTED ON (B)(6) 2020, AND WAS EXPLANTED ON (B)(6) 2021. NO LOT NUMBER WAS PROVIDED, AND THE PRODUCT WAS NOT RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. WITHOUT ADDITIONAL INFORMATION, IT IS UNKNOWN WHETHER THE ADVERSE EVENT OCCURRED DUE TO SURGICAL TECHNIQUES, PATIENT PATHOLOGY OR OTHER CONDITIONS.

  Patient problems: Erosion

  MAUDE report 14274595 ↗
• MalfunctionSep 2, 2020Crack

  UPON OPENING THE PRODUCT TO PREPARE FOR SURGERY, THE END OF THE INTRODUCER WAS FOUND TO BE CRACKED. THE PRODUCT NEVER CAME INTO CONTACT WITH THE PATIENT AND WAS OFF THE FIELD PRIOR TO PATIENT BEING IN THE ROOM. NEW SLING WAS OPENED TO USE FOR THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 10482298 ↗
• InjuryAug 27, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SURGEON PERFORATED THE BLADDER TO THE EXTENT WHERE MESH ENTERED THE BLADDER, THE SLING HAD TO BE REMOVED AND THE PROCEDURE COULD NOT BE COMPLETED. SURGEON SUSPECTED THAT HE MAY NOT HAVE DISPLACED THE BLADDER FAR ENOUGH WITH A CATHETER TO AVOID PERFORATING THE BLADDER WITH THE INSTRUMENT.

  Patient problems: Bowel Perforation

  MAUDE report 10460409 ↗
• InjuryMar 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON HAD 3 (THREE) PATIENTS WHO HAD A SIGNIFICANT PAIN REACTION IN THE MONS AREA. THEY HAVE A LOT OF INFLAMMATION, TENDERNESS WITH FIRM REACTION TISSUE IN THE RETROPUBIC SPACE. IT DOES NOT LOOK INFECTED. THE SURGEON AND SALES REPRESENTATIVE HAVE BEEN CONTACTED FOR FURTHER INFORMATION. THIS SUBMISSION IS MDR 1 OF THE 3 REPORTED ADVERSE EVENTS.

  Patient problems: Inflammation; Pain

  MAUDE report 9779409 ↗
• InjuryMar 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON HAD 3 (THREE) PATIENTS WHO HAD A SIGNIFICANT PAIN REACTION IN THE MONS AREA. THEY HAVE A LOT OF INFLAMMATION, TENDERNESS WITH FIRM REACTION TISSUE IN THE RETROPUBIC SPACE. IT DOES NOT LOOK INFECTED. THE SURGEON AND SALES REPRESENTATIVE HAVE BEEN CONTACTED FOR FURTHER INFORMATION. THIS SUBMISSION IS MDR 2 OF THE 3 REPORTED ADVERSE EVENTS.

  Patient problems: Inflammation; Pain

  MAUDE report 9779398 ↗
• InjuryMar 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON HAD 3 (THREE) PATIENTS WHO HAD A SIGNIFICANT PAIN REACTION IN THE MONS AREA. THEY HAVE A LOT OF INFLAMMATION, TENDERNESS WITH FIRM REACTION TISSUE IN THE RETROPUBIC SPACE. IT DOES NOT LOOK INFECTED. THE SURGEON AND SALES REPRESENTATIVE HAVE BEEN CONTACTED FOR FURTHER INFORMATION. THIS SUBMISSION IS MDR 3 OF THE 3 REPORTED ADVERSE EVENTS.

  Patient problems: Inflammation; Pain

  MAUDE report 9774787 ↗
• InjuryDec 5, 2019Device Damaged by Another Device; Device Damaged by Another Device

  SALES REPRESENTATIVE REPORTS, THAT DR.(B)(6) DURING ONE OF HER SLING IMPLANTS RAN INTO A USER ERROR WHICH LEAD TO AN ADVERSE EVENT. DR. (B)(6) CORRECTLY LOADED THE TROCAR IN THE DESARA TV DILATOR TUBE, WHILE SHE WAS MAKING HER PASS, SHE RE-ADJUSTED AND PULLED THE TROCAR SLIGHTLY BACK OUT BUT DID NOT REALIZE THE DILATOR TUBE WAS NOT FULLY EXTRACTED WITH THE TROCAR. THEREFORE, WHEN DR. (B)(6) MADE HER PASS AGAIN THE TROCAR TIP WAS NOT FULLY THROUGH THE TUBE AND ENDED UP PUNCTURING THROUGH THE TUBE AFTER SHE EXITED THE ABDOMEN. DR. (B)(6) COULD NOT CLAMP THE DILATOR TUBE AFTER THE EXIT THROUGH THE ABDOMEN BECAUSE IT WAS BENT IN THE PATIENTS NEEDLE PASSAGE PATH. THE EVENT DID NOT RESULT PATIENT INJURY AND SURGERY PROLONG ONLY 2-3 MIN. DR. (B)(6) WAS ABLE TO USE A NEW SLING AND IMPLANT SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9419678 ↗
• InjuryDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED THAT DR. (B)(6) PATIENT EXPERIENCED AN EXTRUSION USING DESARA BLUE TV. SURGEON JUST SUTURED UP THE EXTRUSION AND IS HOPING THAT WILL SOLVE THE PROBLEM. THE PATIENT WAS NOT EXPERIENCING ANY PAIN OR DISCOMFORT, ALTHOUGH DR. (B)(6) IS CONCERNED SHE MAY EXPERIENCE PAINFUL INTERCOURSE. HE IS GOING TO CONTINUE TO MONITOR HER AND IF NECESSARY HE WILL CUT OUT THE PIECE OF MESH THAT IS EXTRUDING.

  Patient problems: Erosion

  MAUDE report 9419630 ↗
• InjuryJun 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED VIA EMAIL THAT A PHYSICIAN MENTIONED AN ADVERSE OUTCOME ON (B)(6) 2018 FROM VERTESSA LITE AND DESARA BLUE TV. "THE PATIENT HAD AN EROSION AND EXTRUSION." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SURGEON INCLUDING DETAILS, TREATMENT, AND LOT NUMBERS ASSOCIATED WITH EACH ISSUE. DR. RESPONDED WITH ADDITIONAL INFORMATION: "I CAN TRY TO ASK IN O.R. IF THEY CAN LOOK UP LOT NUMBER, I FOUND SOME INFO IN EPIC. DATE OF SURGERY (B)(6) 2018. MIDURETHRAL MESH EXPOSURE, MIDLINE AND TO THE RIGHT SIDE. USING ESTROGEN CREAM BEFORE AND AFTER SURGERY. TREATED WITH ESTROGEN, BUT VERY TENDER AND COULD NOT TOLERATE OFFICE TRIM FOR MESH REMOVAL. (B)(6) 2018 SLING EXCISION AND CYSTOSCOPY PLANNED. I WILL LET YOU KNOW IF ANYTHING UNUSUAL." SALES REP PROVIDED ADDITIONAL INFORMATION: "I EMAILED DR. (B)(6) LAST NIGHT ASKING FOR CLARIFICATION ON THE VL EROSION. SHE MENTIONED THAT TO ME LAST WEEK WHEN I SAW HER BUT DIDN'T MENTION IT IN THE EMAIL SHE SENT YESTERDAY. SHE TOLD ME THE VL WAS ERODING AT THE APEX OF THE PATIENT'S VAGINA. SHE MENTIONED THE DESARA WAS CAUSING MORE OF A DISCOMFORT FOR THE PATIENT'S HUSBAND DURING INTERCOURSE BUT LED ME TO BELIEVE IT WAS EXTRUDING AS WELL. I WILL

  Patient problems: Erosion

  MAUDE report 8725048 ↗