iTIND System MT-FA04Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07290015518062), received between May 20, 2021 and Jul 28, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Break” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Break; Difficult to Remove

  It was reported from the Physician, a 13/15 Fr access sheath had been planned for the removal procedure; however, only a 12/14 Fr sheath was available. During the office removal procedure, the device could not be retrieved using the available sheath. Assistance was requested from two experienced physicians. During a subsequent retrieval attempt, the device suture broke near the tip of the penis. An attempt to attach an additional suture was unsuccessful. The patient was admitted to the hospital and underwent operative retrieval under general anesthesia the following day. The urethral stricture was dilated to allow insertion of a rigid 19 Fr cystoscope. The remaining suture was captured using a basket and threaded through the cystoscope; however, the suture broke again during withdrawal. According to the physician, the device had been pulled into the cystoscope but significant resistance was encountered. Ultrasound examination reportedly demonstrated that the device had engaged a portion of the bladder wall. The device was released back into the bladder and was subsequently removed intact using alternative endoscopic instruments through the 19 Fr cystoscope. No device components rem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50056816 ↗
• InjuryJul 28, 2026Break; Difficult to Remove; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  As reported: "Miski Petkovic, Territory Manager - iTind, Regional Sales - iTind Central (120002783), called to report an iTind device incident for documentation purposes. The incident occurred on Friday, but he became aware of it yesterday. During retrieval, the device became trapped approximately halfway, requiring the use of an access sheath to assist with removal. The device was broken, and it was being pulled out of the sheath and out of the patient's bladder during the retrieval process. No device lot number was available at the time of the call. A case was created to document the reported event, and the case number will be sent to his email address for future reference."Additional information was requested in email on 14/07/2026.On 15/07/2026, received the following email: "Hi,The customer responded with the following:1. What exactly was broken during the retrieval procedure? This is the message I sent to my local team.I placed an itind in a patient who does CIC a couple weeks ago. The only reason I did an itind is because he has severe bulbar and membranous urethral strictures that cannot accommodate anything larger than a flexible cystoscope. He came in last Wednesday for h

  Patient problems: Physical Entrapment; Rupture

  MAUDE report 50055480 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO URINATE SINCE THE ITIND PROCEDURE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AROUND MIDNIGHT WITH ACUTE URINARY RETENTION. IT WAS NOTED THAT THE BLADDER SCAN SHOWED OVER 800 ML OF FLUIDS AND A CATHETER WAS PLACED TO DRAIN THE BLADDER. THE PATIENT WAS THEN DISCHARGE WITH A CATHETER AND URINE BAG IN PLACED. THE PLAN IS TO KEEP THE CATHETER UNTIL THE RETRIEVAL OF THE ITIND DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: Urinary Retention

  MAUDE report 25255745 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ITIND REMOVAL PROCEDURE UNDER SEDATION IN A 60-YEAR-OLD MALE, THE SUTURE STRING BROKE HALFWAY DOWN SO SOME OF THE STRING WAS STILL OUTSIDE THE PATIENT. AN ATTEMPT TO ATTACH THE STRING TO A 0 EITHIBOND FAILED, SO ANOTHER ATTEMPT WAS MADE TO ATTACH TO A REMOVAL SNARE WHICH ALSO FAILED. THUS, THE PROCEDURE WAS CONVERTED TO AN OPERATION ROOM PROCEDURE TO REMOVE IT WITH A CYSTOSCOPE UNDER SEDATION. PATIENT WAS REPORTED TO HAVE MORE DISCOMFORT THAN ORDINARY DUE TO THE MULTIPLE ATTEMPTS, BUT NO PERSISTENT OR LONG-TERM NEGATIVE EFFECTS WERE REPORTED THE PROCEDURE WAS DELAYED BY GREATER THAN 30 MINUTES. THE INITIAL REMOVAL ATTEMPT WAS APPROXIMATELY 15 MINUTES, HOWEVER, IT TOOK ABOUT AN HOUR TO OBTAIN ANESTHESIA CONSENT AND TO TRANSITION THE PATIENT INTO THE OR SETTING. ONCE IN THE OR THE SUCCESSFUL REMOVAL OF THE ITIND WAS LESS THAN 10 MINUTES. THERE WERE NO FURTHER REPORTS OF PATIENT IMPACT.

  Patient problems: Discomfort

  MAUDE report 24526646 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE POST-IMPLANT VISIT, THE PATIENT STATED PAIN DISRUPTED HIS DAILY ACTIVITIES, AFFECTING HIS ATTENDANCE AT WORK DUE TO DISCOMFORT. HE HAD TO LEAVE WORK EARLY DUE TO INTENSE PAIN AND PRESSURE AND A CONSTANT NEED TO URINATE. THE PATIENT RATED THE PAIN TEN OUT OF TEN. THE PAIN RESOLVED AFTER THE DEVICE REMOVAL VISIT. THERE WERE NO FURTHER REPORTS OF PATIENT IMPACT.

  Patient problems: Implant Pain; Micturition Urgency

  MAUDE report 23437818 ↗
• InjurySep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE SUBJECT DEVICE; THE PHYSICIAN UTILIZED A COOK FLEXOR PARALLEL ACCESS SHEATH. DUE TO ITS DESIGN, THE SHEATH CUT THE SUTURE AT THE HUB OF THE SUBJECT DEVICE. REPORTEDLY, THE PROCEDURE WAS PROLONGED BY AT LEAST OR GREATER THAN 30 MINUTES. AS A RESULT, THE PATIENT WAS MOVED TO THE OPERATING ROOM FOR SEDATION, AND THE DEVICE WAS SUCCESSFULLY REMOVED USING A CYSTOSCOPE SHEATH AND GRASPER. THERE WERE NO REPORTS OF FURTHER PATIENT IMPACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY OLYMPUS, BUT NO FURTHER INFORMATION WAS RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978730 ↗
• InjuryMar 25, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED AFTER REMOVAL OF AN ITIND, ON AN UNSPECIFIED DATE, THE PATIENT ACQUIRED A URINARY TRACT INFECTION AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR SEPSIS. IT WAS NOTED THAT THE REMOVAL OF THE ITIND DID NOT GO IDEALLY AS THE DEVICE DID NOT COME FULLY INTO THE REMOVAL CATHETER. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. DESPITE MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION, NONE WAS OBTAINED. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIER: (B)(6).

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 21691539 ↗
• InjuryMar 25, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED AFTER REMOVAL OF AN ITIND, ON AN UNSPECIFIED DATE, THE PATIENT ACQUIRED A URINARY TRACT INFECTION AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR SEPSIS. IT WAS NOTED THAT THE REMOVAL OF THE ITIND DID NOT GO IDEALLY AS THE DEVICE DID NOT COME FULLY INTO THE REMOVAL CATHETER. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. DESPITE MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION, NONE WAS OBTAINED. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIER: (B)(6).

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 21691538 ↗
• InjuryDec 30, 2024Defective Component; Migration; Defective Component; Migration

  IT WAS REPORTED THE FOLLOWING DAY AFTER A BPH (BENIGN PROSTATIC HYPERPLASIA) TREATMENT PROCEDURE, THE PATIENT COMPLAINED OF EXCESSIVE LEAKING OF URINE. IT WAS FOUND OUT THAT THIS IMPLANTABLE SUBJECT DEVICE HAD MIGRATED. A MEDICAL INTERVENTION WAS DONE TO ANCHOR THE SUBJECT DEVICE AGAIN WITH NO SUCCESS. THE SUBJECT DEVICE WAS REMOVED, AND IT WAS FOUND THE ANCHORING LEAF SEEMED DEFECTIVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN OLYMPUS BACK UP DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 21044404 ↗
• InjuryDec 13, 2024Break; Break

  IT WAS REPORTED THAT DURING THE REMOVAL PROCEDURE OF THE SUBJECT DEVICE, THE SUTURE THAT IS USED TO PULL THE DEVICE INTO A CATHETER BROKE. THE PATIENT HAD TO BE MOVED TO THE OPERATING ROOM TO HAVE THE SUBJECT DEVICE SURGICALLY REMOVED USING A CYSTOSCOPE. THE SUBJECT DEVICE WAS SUCCESSFULLY REMOVED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922258 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ACUTE URINARY RETENTION FOLLOWING THE APPLICATION OF THE SUBJECT DEVICE. IT WAS NOTED THAT DUE TO THE PATIENT'S ANATOMICAL PRESENTATION, THERE WAS DIFFICULTY IN THE APPLICATION OF THE SUBJECT DEVICE, CONTRIBUTING TO THE RETENTION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR MANAGEMENT OF URINARY RETENTION. THE TREATMENT INCLUDED FOLEY CATHETER PLACEMENT, INTRAVENOUS ANTIBIOTICS FOR SUSPECTED INFECTION, INTRAVENOUS HYDRATION, AND MONITORING OF RENAL FUNCTION. THE URINARY RETENTION LED TO ACUTE KIDNEY INJURY, WHICH WAS RESOLVED WITH MANAGEMENT DURING THE STAY. DURING THE HOSPITALIZATION, THE SUBJECT DEVICE WAS REMOVED. ADDITIONALLY, AS REPORTED, THE HOSPITALIZATION WAS PROLONGED DUE TO THE PATIENT'S PRE-EXISTING CONDITIONS, INCLUDING ADRENAL INSUFFICIENCY, POORLY CONTROLLED DIABETES, AND CHRONIC IMMUNOSUPPRESSION THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Renal Impairment; Urinary Retention

  MAUDE report 20909702 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE ITIND, THE SUTURE BECAME DETACHED FROM THE HUB. THE REMOVAL PROCEDURE WAS NOT PERFORMED UNDER ANESTHESIA, ONLY A LOCAL TOPICAL GEL. THE PROCEDURE TOOK ROUGHLY TWO HOURS AND THE PATIENT EXPERIENCED "ADDITIONAL TRAUMA" TO THE URETHRA FROM MULTIPLE REMOVAL ATTEMPTS. A CYSTOSCOPE WAS ULTIMATELY REQUIRED, IN ADDITION TO GRASPING FORCEPS, TO REMOVE THE DEVICE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. FOLLOWING THE PROCEDURE, THERE WERE NO OTHER INJURIES.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 20493451 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS DEPLOYED BLINDLY IN THE PATIENT'S BLADDER THROUGH A RIGID CYSTOSCOPE SHEATH DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE DEVICE SLIGHTLY PUNCTURED THE BLADDER CAUSING A SMALL PERFORATION. THERE WAS NO INTRAPERITONEAL INJURY, SO THE DOCTOR DECIDED TO PLACE THE DEVICE WHILE LEAVING A CATHETER TO ASSIST IN VOIDING AND HEALING. THE PATIENT SINCE HAD THE DEVICE REMOVED AND WAS STATED TO BE DOING FINE. THE DOCTOR PLANS ON SCOPING THE PATIENT IN 3 MONTHS FOR FOLLOW UP.

  Patient problems: Internal Organ Perforation

  MAUDE report 20392606 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CALLED IN ON (B)(6) 2024 WITH COMPLAINT OF HEMATURIA AND CAME FOR A VISIT ON (B)(6) 2024. IT WAS NOTED PATIENT HAD HEMATOSPERMIA. SEMEN CULTURE (SAMPLE COLLECTED ON (B)(6) 2024) RESULTED IN DIAGNOSIS OF PROSTATITIS ((B)(6) 2024). AND PATIENT WAS ADMINISTERED LEVAQUIN FOR POSSIBILITY OF INFECTION. DETAILS OF THE PATIENT'S CURRENT CONDITION, PROCEDURAL DETAILS AND OUTCOME OF THE PROCEDURE WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 19343480 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED, A PATIENT WHO HAD THE SUBJECT DEVICE IMPLANTED DEVELOPED A DRUG RESISTANT URINARY TRACT INFECTION (UTI), HAD TO BE GIVEN INTRAVENOUS (IV) ANTIBIOTICS, AND WAS HOSPITALIZED. THE PROVIDER LATER REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2024, AND EXPLANTED ON (B)(6) 2024. FIVE DAYS AFTER EXPLANT, THE PATIENT STARTED EXPERIENCING CHILLS, WEAKNESS, NAUSEA, AND ALTERED MENTAL STATUS. THEY PRESENTED TO THE HOSPITAL AND WAS FOUND TO HAVE A MULTI DRUG RESISTANT UTI WITH A URINE CULTURE POSITIVE FOR MORGANELLA MORGANII. THE PATIENT WAS TREATED WITH ERTAPENEM ANTIBIOTIC THERAPY FOR 7 DAYS WITH RESOLUTION OF SYMPTOMS AS OF POST OPERATIVE CHECK ON (B)(6) 2024. OF NOTE, THE PATIENT HAD A NEGATIVE PRE-IMPLANT URINE CULTURE AND RECEIVED SINGLE-DOSE IV ANTIBIOTICS AT THE TIME OF PRE-IMPLANTATION AND EXPLANTATION. THERE WERE NO REPORTS OF FURTHER PATIENT HARM. DUE TO SYSTEM LIMITATION FOR THE D2 FIELD, THE MORE ACCURATE DEVICE PRODUCT CODE IS BEING ENTERED HERE: QKA - TEMPORARILY-PLACED URETHRAL OPENING SYSTEM FOR SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA.

  Patient problems: Chills; Drug Resistant Bacterial Infection; Fever; Muscle Weakness/Atrophy; Nausea; Unspecified Mental, Emotional or Behavioral Problem; Urinary Tract Infection

  MAUDE report 19121026 ↗
• InjuryDec 13, 2022Unexpected Therapeutic Results

  THE CUSTOMER REPORTS AFTER AN ITIND REMOVAL PROCEDURE, THE PATIENT RETURNED A FEW HOURS AFTER REMOVAL, WITH COMPLAINTS OF URINARY RETENTION. A 16FR FOLEY CATHETER WAS PLACED AND 480 ML OF RED COLORED URINE WAS DRAINED. PATIENT WILL RETURN AT A LATER DATE TO HAVE CATHETER REMOVED. NO FURTHER CONSEQUENCES TO THE PATIENT WERE REPORTED. REPRESENTATIVE PROCODE MER CHOSEN IN FIELD. ACTUAL PROCODE QKA FOR ITIND.

  Patient problems: Hematuria; Urinary Retention

  MAUDE report 15971420 ↗
• InjuryMay 20, 2021Break; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021 2 PROCEDURES WERE PERFORMED AT (B)(6) HOSPITAL, (B)(6). THE FIRST ONE HELD AT 08:45 IN THE MORNING WENT ON WITHOUT ANY PROBLEMS OR COMPLICATIONS. IN THE SECOND PROCEDURE, AFTER THE PASSAGE OF THE ITIND DEVICE INSIDE THE CYSTOSCOPY SHIRT, BY MISTAKE IN THE STEPS OF THE PROCEDURE, THE ITIND SUTURE WAS ACCIDENTALLY PULLED AND IT WAS RELEASED FROM ITS TUBE GUIDE, THIS STEP SHOULD BE DONE ONLY AFTER THE FINAL POSITIONING OF THE ITIND IN THE PROSTATE, BECAUSE AFTER LOOSENING THE SUTURE, THE DEVICE'S MANEUVERABILITY CONTROL IS LOST. THEREFORE, IT WAS RECOMMENDED THAT THE TEAM REMOVE THE DEVICE TO APPLY ANOTHER UNIT. WHEN PERFORMING THE REMOVAL USING THE CYSTOSCOPY SHEET, THE SUTURE BROKE FROM THE ITIND AND IT WAS RELEASED INSIDE THE PATIENT'S BLADDER. TO REMOVE THE DEVICE, IT WAS NECESSARY TO INTRODUCE A 24 FR SHEET FOR PROSTATE RESECTION, THE PROCEDURE WAS CONVERTED TO A MONOPOLAR PROSTATE TRP (TRANSURETHRAL RESECTION OF THE PROSTATE). WHERE THE OBSTRUCTIVE TISSUE WAS REMOVED, AND WITH BETTER FLOW AND BETTER VISUALIZATION, THE ITIND DEVICE WAS COMPLETELY REMOVED WITH THE AID OF AN OPTICAL GRASPING FORCEPS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11853799 ↗