Flexiva Pulse ID M006L8406930Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729978695), received between Mar 24, 2022 and Apr 22, 2026 — classified as 6 injuries, 11 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionApr 22, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, AN ERROR CODE 48 "WOULD NOT RECOGNIZE FIBER" WAS PROMPTED. IT WAS INDICATED THAT THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960842 ↗
• MalfunctionApr 16, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING PROCEDURE, THREE SEPARATE FIBERS WERE TRIED HOWEVER NO ENERGY WOULD PASS DOWN THE FIBER. A CONNECTION ISSUE WAS ALSO INDICATED. THE PATIENT, WHO WAS UNDER GENERAL ANESTHESIA, WAS WOKEN UP AND WILL NEED FURTHER SURGERY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE LASER. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN. DEVICE 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899590 ↗
• MalfunctionApr 15, 2026Melted; Separation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER MELTED AND THE CONNECTOR DETACHED. IT WAS ALSO NOTED THAT THE DEVICE HAD A STRONG BURNT ODOR. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891819 ↗
• MalfunctionDec 19, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A PROCEDURE, THE LASER FIBER HUB OVERHEATED AND MELTED AT THE CONNECTION OF THE CONSOLE (MOSES) LASER DURING ABLATIONS OF STONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20980918 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THE DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, TWO LASER FIBER TIPS FRACTURED INSTANTLY. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER AND NO CLINICAL COMPLICATIONS TO THE PATIENT. THIS REPORT IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727214 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THE DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, TWO LASER FIBER TIPS FRACTURED INSTANTLY. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER AND NO CLINICAL COMPLICATIONS TO THE PATIENT. THIS REPORT IS FOR THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727213 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A HOLEP PROCEDURE, THE TIP OF TWO FIBERS WERE FRACTURED. A THIRD FIBER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS TO REPORT. THIS REPORT IS FOR THE FIRST BROKEN FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069094 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A HOLEP PROCEDURE, THE TIP OF TWO FIBERS WERE FRACTURED. A THIRD FIBER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS TO REPORT. THIS REPORT IS FOR THE SECOND BROKEN FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069093 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) STUDY PROCEDURE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). THE CONSOLE SETTING USED FOR THE PROCEDURE SHOWED PULSE LENGTH LONG, PULSE ENERGY 2 JOULES, PULSE FREQUENCY 30 HZ AND TOTAL LASER ENERGY 60W. THE FIBER WAS NOT STRIPPED OR CLEAVED. THERE WERE NO OTHER ACCESSORY DEVICES INTRODUCED INTO THE PATIENT BODY DURING THE PROCEDURE. DURING THE PROCEDURE, AN INCIDENTAL URETHRAL STRICTURE WAS FOUND AND URETHROTOMY WAS PERFORMED CONCURRENTLY TO ADDRESS THE STRICTURE ISSUE, BUT IT WAS NOTED THAT PATIENT HAD A RECURRENT STRICTURE OF THE BULBAR URETHRA. URINARY CATHETER WAS PLACED ON THE PROCEDURE DATE AND REMOVED ONE DAY POST PROCEDURE. THE PATIENT DISCHARGE MEDICATIONS INCLUDED COLACE FOR CONSTIPATION PROPHYLAXIS, AND PROSCAR FOR BPH SYMPTOMS PROPHYLAXIS. THE PATIENT EXPERIENCED BLADDER NECK STENOSIS ONE HUNDRED-THIRTEEN (113) DAYS AFTER THE PROCEDURE AND ALSO INCONTINENCE TWO WEEKS POST PROCEDURE. THE PATIENT SYMPTOMS WERE REPORTED TO BE NON-SERIOUS AND RESOLVED. THULIUM LASER INCISION OF URETHRAL STRICTURE, BLADDER NECK STENOSIS WITH CYSTOLITHOLAPAXY, AND THE CATHETERIZATION WERE PERFORMED TO RES

  Patient problems: Urethral Stenosis/Stricture; Urinary Incontinence; Urinary Retention

  MAUDE report 17795589 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) STUDY PROCEDURE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). THE CONSOLE SETTING USED FOR THE PROCEDURE SHOWED PULSE LENGTH LONG, PULSE ENERGY 2 JOULES, PULSE FREQUENCY 40 HZ AND TOTAL LASER ENERGY 80W. THE FIBER WAS STRIPPED ONCE BEFORE PROCEDURE. THERE WERE NO OTHER ACCESSORY DEVICES INTRODUCED INTO THE PATIENT BODY DURING THE PROCEDURE. NO ADVERSE EVENTS WERE NOTED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. URINARY CATHETER WAS PLACED ON THE PROCEDURE DAY AND REMOVED ONE DAY POST PROCEDURE AT DISCHARGE. THE PATIENT DISCHARGE MEDICATIONS INCLUDED MIRALAX FOR CONSTIPATION PROPHYLAXIS AND PYRIDIUM FOR PAINFUL URINATION PROPHYLAXIS. THE PATIENT EXPERIENCED IRRITATIVE URINARY SYMPTOMS THE SAME DAY THE PROCEDURE WAS PERFORMED (POST PROCEDURE). THE PATIENT SYMPTOMS WERE REPORTED TO BE NOT SERIOUS. MEDICATION WAS ADMINISTERED AND THE DOSE WAS INCREASED. THE PATIENT SYMPTOMS WERE REPORTED TO BE ON GOING. THE STUDY FACILITY ASSESSED THE PATIENT SYMPTOMS AS POSSIBLY RELATED TO THE LITHOTRIPSY PROCEDURE AND POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Dysuria; Micturition Urgency; Urinary Frequency / Polyuria

  MAUDE report 17410486 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) STUDY PROCEDURE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). THE CONSOLE SETTING USED FOR THE PROCEDURE SHOWED PULSE LENGTH LONG, PULSE ENERGY 2 JOULES, PULSE FREQUENCY 30HZ AND TOTAL LASER ENERGY 60W. THE FIBER WAS NOT STRIPPED DURING THE PROCEDURE. THERE WERE NO OTHER ACCESSORY DEVICES INTRODUCED INTO THE PATIENT BODY DURING THE PROCEDURE. NO ADVERSE EVENTS WERE NOTED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A URINARY CATHETER WAS PLACED AFTER THE PROCEDURE AND REMOVED THE NEXT DAY. THE PATIENT DISCHARGE MEDICATION INCLUDED SENNA AND COLACE FOR CONSTIPATION PROPHYLAXIS, KEFLEX FOR POST-OPERATIVE ANTIBIOTIC PROPHYLAXIS, AND PROSCAR FOR PREVENTION OF BPH SYMPTOMS. THE PATIENT BEGAN EXPERIENCING DYSURIA AND URINARY FREQUENCY SIXTY-SIX (66) DAYS POST PROCEDURE. THE PATIENT SYMPTOMS WERE REPORTED TO BE RESOLVED, AND NOT SERIOUS. THE DYSURIA WAS RESOLVED ON 28JUN2023 AND THE URINARY FREQUENCY WAS RESOLVED ON 08JUN2023. THE STUDY FACILITY ASSESSED THE DYSURIA AND THE URINARY FREQUENCY AS POSSIBLY RELATED TO THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE AND N

  Patient problems: Dysuria; Urinary Frequency / Polyuria

  MAUDE report 17337474 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) STUDY PROCEDURE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). THE CONSOLE SETTING USED FOR THE PROCEDURE SHOWED PULSE LENGTH LONG, PULSE ENERGY 2 JOULES, PULSE FREQUENCY 40 HZ AND TOTAL LASER ENERGY 80W. THE FIBER WAS NOT STRIPPED DURING THE PROCEDURE BUT STRIPPED ONCE BEFORE PROCEDURE. THERE WERE NO OTHER ACCESSORY DEVICES INTRODUCED INTO THE PATIENT BODY DURING THE PROCEDURE. NO ADVERSE EVENTS WERE NOTED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. URINARY CATHETER WAS PLACED ON THE PROCEDURE DATE AND REMOVED ONE DAY POST PROCEDURE. THE PATIENT DISCHARGE MEDICATIONS INCLUDED INCLUDED SENNA FOR CONSTIPATION PROPHYLAXIS, BACITRACIN FOR CATHETER PAIN PROPHYLAXIS, AND OMNICEF FOR INFECTION PROPHYLAXIS. THE PATIENT EXPERIENCED IRRITATIVE URINARY SYMPTOMS THE SAME DAY THE PROCEDURE WAS PERFORMED. THE PATIENT SYMPTOMS WERE REPORTED TO BE NOT SERIOUS. THE PATIENT SYMPTOMS WERE REPORTED TO BE ON GOING. THE STUDY FACILITY ASSESSED THE PATIENT SYMPTOMS AS POSSIBLY RELATED TO THE LITHOTRIPSY PROCEDURE AND NOT RELATED TO THE DEVICE.

  Patient problems: Dysuria

  MAUDE report 17334102 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE STUDY PROCEDURE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). THE CONSOLE SETTING USED FOR THE PROCEDURE SHOWED PULSE LENGTH LONG, PULSE ENERGY 2J, PULSE FREQUENCY 40HZ AND TOTAL LASER ENERGY 80W. THE FIBER WAS STRIPPED ONE TIME BEFORE THE PROCEDURE. THERE WERE NO OTHER ACCESSORY DEVICES INTRODUCED INTO THE PATIENT BODY DURING THE PROCEDURE. NO ADVERSE EVENTS WERE NOTED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A URINARY CATHETER WAS PLACED ON THE PROCEDURE DAY AND REMOVED THREE DAYS POST PROCEDURE. THE PATIENT DISCHARGE MEDICATION INCLUDED SENNOSIDES FOR CONSTIPATION PROPHYLAXIS. THE PATIENT BEGAN EXPERIENCING IRRITATIVE URINARY SYMPTOMS ON THE PROCEDURE DAY (POST PROCEDURE). THE PATIENT SYMPTOMS WERE REPORTED TO BE NOT SERIOUS, ONGOING AND NO ACTION WAS TAKEN. THE STUDY FACILITY ASSESSED IRRITATIVE URINARY SYMPTOMS AS PROBABLY RELATED TO HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. ALSO, THE PATIENT BEGAN EXPERIENCING URINARY INCONTINENCE FIFTY-ONE DAYS POST PROCEDURE. THE PATIENT SYMPTOM WAS REPORTED TO BE NOT SERIOUS, AND NO

  Patient problems: Dysuria; Micturition Urgency; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 17125268 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE STUDY PROCEDURE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA. THE CONSOLE SETTING USED FOR THE PROCEDURE SHOWED PULSE LENGTH LONG, PULSE ENERGY 2J, PULSE FREQUENCY 30HZ AND TOTAL LASER ENERGY 60W. THE FIBER WAS NOT STRIPPED OR CLEAVED. THERE WERE NO OTHER ACCESSORY DEVICES INTRODUCED INTO THE PATIENT BODY DURING THE PROCEDURE. NO ADVERSE EVENTS WERE NOTED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A URINARY CATHETER WAS PLACED ON THE DATE OF THE PROCEDURE AND REMOVED NEXT DAY OF THE PROCEDURE. THE PATIENT DISCHARGE MEDICATION INCLUDED COLACE AND SENOKOT FOR CONSTIPATION PROPHYLAXIS, TYLENOL FOR POSTOPERATIVE PAIN PROPHYLAXIS, AND PROSCAR TO PREVENT BPH SYMPTOMS. THE PATIENT BEGAN EXPERIENCING ACUTE URINARY RETENTION FOUR DAYS POST PROCEDURE. CATHETERIZATION WAS PERFORMED FROM SYMPTOM ONSET DAY TO TWELVE DAYS POST ONSET SYMPTOM. THE PATIENT SYMPTOM OF ACUTE URINARY RETENTION WAS REPORTED TO BE NOT SERIOUS AND RESOLVED ON THE DAY OF ONSET SYMPTOM. THE STUDY FACILITY ASSESSED THE ACUTE URINARY RETENTION SYMPTOM AS CAUSALLY RELATED TO THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE P

  Patient problems: Urinary Retention

  MAUDE report 17010958 ↗
• MalfunctionAug 19, 2022Break; Break

  IT WAS REPORTED THAT THE FIBER WAS CONNECTED TO THE CONSOLE AND A BREAK WAS DETECTED. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260298 ↗
• MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS USED IN A BLADDER STONE PROCEDURE PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING PREPARATION, THE PHYSICIAN NOTICED THAT THE LASER FIBER JACKET COVER EXTENDED TO THE VERY END OF THE LASER FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA PULSE ID LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14147917 ↗
• MalfunctionMar 24, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT FLEXIVA PULSE ID LASER FIBERS HAVE BEEN USED DURING URETEROSCOPY PROCEDURES TO TREAT STONES IN THE KIDNEY. DURING THE PROCEDURE, THE LASER FIBERS WERE FOUND TO BE DEFECTIVE. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. DESPITE GOOD FAITH EFFORTS, NO INFORMATION HAS BEEN RECEIVED TO DATE TO CLARIFY THE NUMBER OF FIBERS THAT WERE DEFECTIVE, THE NATURE OF THE DEFECTS AND THE DATE OR DATES THE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895732 ↗