Flexiva Pulse IDRecalls & reported problems across all models

We found 5 models of Flexiva Pulse ID by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2021 and Sep 16, 2026 — classified as 15 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Break” (47 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Flexiva Pulse ID recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 25, 2023Open, Classified

   Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

   Z-2234-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. May 25, 2023Open, Classified

   Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

   Z-2233-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. May 25, 2023Open, Classified

   Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

   Z-2232-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. May 25, 2023Open, Classified

   Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

   Z-2231-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Flexiva Pulse ID problems

Flexiva Pulse ID models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Flexiva Pulse ID M006L8406910

  Powered laser surgical instrument
  2 recalls26 reports
• Flexiva Pulse ID M006L8406960

  Powered laser surgical instrument
  2 recalls18 reports
• Flexiva Pulse ID M006L8406930

  Powered laser surgical instrument
  17 reports
• Flexiva Pulse ID M006L8406940

  Powered laser surgical instrument
  15 reports
• Flexiva Pulse ID M006L8406920

  Powered laser surgical instrument
  8 reports

Recent Flexiva Pulse ID adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793193 ↗
• MalfunctionJun 1, 2026

  FROM OPERATIVE REPORT: FIRST ATTEMPTED TO PERFORM LITHOTRIPSY USING THE TRILOGY DEVICE AT THE HIGHEST SETTING BUT THIS WAS MAKING VERY LITTLE IMPACT ON THE STONE DUE TO ITS VERY HIGH DENSITY. THE DECISION WAS THEN MADE TO USE A 1000 MICRON HOLMIUM LASER FIBER FOR LITHOTRIPSY INSTEAD. LITHOTRIPSY WAS THEN BEGUN USING A POWER OF 100 W. HOWEVER, AFTER ABOUT 15 MINUTES OF LITHOTRIPSY THE FIBER BROKE DUE TO THE HIGH POWER. A NEW FIBER WAS THEN PLACED AND USING A SLIGHTLY LOWER POWER OF 75 W LITHOTRIPSY WAS CONTINUED. AFTER LITHOTRIPSY WAS COMPLETED ON ONE OF THE LARGE STONES, OPERATIVE TIME WAS APPROACHING 3 HOURS AND THE DECISION WAS MADE TO STOP HERE FOR THE DAY. THE TRILOGY WAS THEN REINSERTED AND USED TO CLEAR THE REMAINING DUST AND FRAGMENTS. THE NEPHROSCOPE WAS THEN REMOVED. A 22 FRENCH COUNCIL TIP FOLEY CATHETER WAS THEN INSERTED THROUGH THE ACCESS SHEATH INTO THE POUCH AND THE BALLOON INFLATED WITH 10 ML OF STERILE WATER. THE ACCESS SHEATH WAS THEN CUT SO IT COULD BE REMOVED OVER THE CATHETER. CONTRAST AND SALINE WERE THEN INJECTED THROUGH THE CATHETER INTO THE POUCH TO CONFIRM PLACEMENT. ALL WIRES WERE THEN REMOVED. THE SUPRAPUBIC TUBE WAS SECURED USING A 2-0 NYLON DRAIN STITCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347558 ↗
• MalfunctionMay 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE FIBER WAS CONNECTED TO THE LASER WHEN A SOUND WAS HEARD, AND THE TIP WAS FOUND TO BE BURNED. THE PRODUCT DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150968 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING PREPARATION OF A URETEROSCOPY PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, WHEN THE FIBER WAS CONNECTED TO THE CONSOLE, AN ERROR APPEARED INDICATING ERROR 66 (PLEASE USE AUTHORIZED FIBER). AN ANOTHER FIBER WAS TRIED, HOWEVER NEITHER WERE COMPATIBLE WITH THE CONSOLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN. THIS COMPLAINT IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143100 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, IT WAS INDICATED THAT THE DEVICE WAS BROKEN/FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050526 ↗
• MalfunctionApr 28, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE FIBER TIP WAS BROKEN OFF UPON OPENING FROM STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BODY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020827 ↗
• 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 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER BROKE APPROXIMATELY FOUR CENTIMETERS FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891619 ↗
• InjuryApr 14, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS BROKEN IN THE RENAL CALYX. IT WAS NOTED THAT THE LASER TIP WAS REMOVED INTACT USING A BASKET. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868061 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING URETEROSCOPY, THE FIBER BROKE AND STOPPED WORKING. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678210 ↗
• InjuryFeb 27, 2026Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING URETEROSCOPY, THE TIP OF THE FIBER BURNED OUT DURING ACTIVATION, AND THE TIP SEPARATED FROM THE FIBER. THE TIP REMAINED INSIDE THE PATIENT. THE DISCONNECTED TIP WAS IRRIGATED OUT OF THE PATIENT WITH SALINE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474518 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE AS THE PHYSICIAN WAS ADVANCING IT INTO THE SCOPE. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415309 ↗
• MalfunctionFeb 9, 2026

  DURING URETEROSCOPY, THE TIP OF THE LASER FIBER BURNED OUT DURING ACTIVATION, AND THE TIP SEPARATED FROM THE FIBER AND REMAINED INSIDE THE PATIENT. THE DISCONNECTED TIP WAS IRRIGATED OUT OF THE PATIENT WITH SALINE. MANUFACTURER RESPONSE FOR POWERED LASER SURGICAL INSTRUMENT, FLEXIVA PULSE ID (PER SITE REPORTER).

  Patient problems: Insufficient Information

  MAUDE report 24291104 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports