Desara CAL-DS01 (UDI 00890594000629)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00890594000629), received between Nov 1, 2017 and Jun 21, 2019 — classified as 3 injuries.

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

• InjuryJun 21, 2019No Apparent Adverse Event; No Apparent Adverse Event

  SALES REP. (B)(6) CALLED/EMAILED THE CORPORATE TEAM TO ADVISE ON THE FOLLOWING COMPLAINT: A PORTION OF DESARA CLEAR SLEEVE MAY HAVE BEEN INADVERTENTLY LEFT INSIDE THE PATIENT. DUE TO A UNIQUE MEDICAL CONDITION WITH THE PATIENT, THE SURGEON HAD TO "TENSION THE SLING MUCH TIGHTER THAN NORMAL AND WHEN SHE CUT THE SLING, SHE BELIEVES THERE IS A CHANCE THAT A SMALL PIECE OF SHEATH TUCKED BACK INTO THE SUPRAPUBIC INCISION WITH THE SLING". DURING THE PHONE CALL FROM THE REP AND SURGEON TO CORPORATE, THE SURGEON ASKED IF IT WAS ACCEPTABLE TO LEAVE THE SLEEVE INSIDE THE PATIENT. CMI INFORMED THE SURGEON THAT THE SLEEVE IS NOT INTENDED FOR LONG-TERM USE AND DOES NOT RECOMMEND LEAVING IT INSIDE THE PATIENT. PER SALES REP EMAIL (SAME DAY), UPON EVALUATION OF THE REMAINING PORTION OF THE SLING, THE SURGEON AND REP DID NOT BELIEVE THAT ANY PORTION OF THE SLEEVE WAS LEFT INSIDE OF THE PATIENT'S BODY. HOWEVER, THE REMAINING PORTION OF THE DEVICE WAS RETURNED TO CORPORATE FOR EVALUATION. PER ENG ANALYSIS, ONLY A PORTION OF THE DEVICE WAS RETURNED, RESULTING IN POTENTIAL 48MM SLEEVE PORTION MISSING. THE REP WAS CONTACTED TO CONFIRM WHETHER OR NOT THIS PORTION WAS THROWN AWAY DURING THE SURGERY. WITH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8725169 ↗
• InjuryJun 21, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DR. (B)(6) HAD AN "ASSIST" WHO WAS HELPING HER TODAY IN HER CASE (DR. (B)(6) WOULDN'T RELEASE IF IT WAS A RESIDENT OR ASSISTANT). THE PERSON HELPING HER CUT THE SHEATH RIGHT AT THE EXIT INCISION WHEN DR.(B)(6) WAS TENSIONING HER SLING. THE SHEATH WAS NOT HELD ON TO AND WAS "SUCKED" BACK INTO THE INCISION. THE SHEATH WAS NOT IN THE PATIENT AND COULD NOT BE RETRIEVED. DR. (B)(6) REMOVED THE PLACED SLING IN HOPES THE SHEATH WOULD COME OUT, BUT IT DIDN'T. THEN SURGEON TRIED TO PLACE ANOTHER SLING, BY PASSING THE TROCAR IN HOPES IT WOULD PUSH THE SHEATH OUT, IT DIDN'T. THE NEW SLING WAS TAKEN OUT OF THE PATIENT, AND DR. (B)(6) CALLED SALES REP TO DISCUSS THIS ISSUE. SALES REP MENTIONED TO SURGEON THE "PLASTIC SHEATH" WOULD NEED TO BE REMOVED FROM THE PATIENT'S BODY. LATER SURGEON WAS ABLE TO DISSECT VAGINALLY AND PULL OUT THE SHEATH. PER DR. (B)(6), THE COMPLAINT SLING WAS DISPOSED OF AFTER SURGERY AND NOT AVAILABLE FOR RETURN. NO SERIOUS INJURY TO THE PATIENT AS A RESULT OF THE PROCEDURE. NO PATIENT CONTRAINDICATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723448 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP REPORTED BLADDER PERFORATION CAUSED BY A MANDRIN (NON-CALDERA INSTRUMENT) DURING IMPLANTATION OF A DESARA SLING. HE STATES THAT THE SURGEON ALREADY PULLED THE SLING THROUGH THE SUPRAPUBIC INCISIONS AND TENSIONED BEFORE SUTURING THE BLADDER. AFTER THE INCIDENT, THE SURGEON COULD NOT FIND THE SLING IN THE CENTER INCISION ANYMORE. SURGEON STATED THAT THE PATIENT'S TISSUE MUST HAVE BEEN TOO WEAK TO SUPPORT IT. IT TOOK HIM ABOUT 10 MINUTES TO FIND THE SLING AND REMOVE IT FROM THE PATIENT. CLARIFICATION WITH THE SURGEON AND SALES REP REVEALED THAT A MANDRIN (NON-CALDERA INSTRUMENT), USED FOR CATHETERIZATION, PUNCTURED THE BLADDER DURING SURGERY.

  Patient problems: Internal Organ Perforation

  MAUDE report 6995258 ↗