Flexiva IDRecalls & reported problems across all models

We found 4 models of Flexiva ID by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 203 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2018 and Jun 27, 2024 — classified as 11 injuries, 192 malfunctions.

The most frequently reported specific device problem is “Break” (121 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. 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

Most reported Flexiva ID problems

Flexiva ID models

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

• Flexiva™ ID M006R8403910

  Powered laser surgical instrument
  137 reports
• Flexiva™ ID M006R8403920

  Powered laser surgical instrument
  27 reports
• Flexiva™ ID M006R8403940

  Powered laser surgical instrument
  20 reports
• Flexiva™ ID M006R8403930

  Powered laser surgical instrument
  19 reports

Recent Flexiva ID adverse event reports

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

• MalfunctionJun 27, 2024Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LASER FIBER WAS NOT TRANSMITTING PROPERLY. NO PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629169 ↗
• MalfunctionJul 5, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA ID LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE FOR A STONE TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT. A STENT WAS PLACE TO ALLOW THE KIDNEY TO DRAIN. THE PROCEDURE, WAS UNABLE TO BE COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914282 ↗
• MalfunctionMay 19, 2022Break; Break

  A FLEXIVA ID LASER FIBER WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION. THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE DEVICE WAS ANALYZED AND THE INVESTIGATION RESULTS REVEALED THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435755 ↗
• MalfunctionMay 12, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT FLEXIVA ID HIGH POWER SINGLE-USE LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377788 ↗
• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 18, 2022 THAT FLEXIVA ID HIGH POWER SINGLE-USE LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR AND FIBER BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377775 ↗
• MalfunctionApr 22, 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 ID HIGH POWER SINGLE USE LASER FIBER WAS USED IN A URETEROSCOPY TO TREAT A STONE IN THE URETER PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A MOSES 1.0 LASER CONSOLE. DURING INSERTION, THE LASER FIBER WAS SEEN TO CLEAVE THROUGH LITHOVUE SCOPE PRIOR TO USE. THE TIP OF THE LASER FIBER WAS BROKEN. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187750 ↗
• MalfunctionApr 20, 2022Degraded; Overheating of Device; Degraded; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA ID HIGH POWER SINGLE USE LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE TO TREAT A STONE IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A MOSES LASER CONSOLE WITH THE LASER SETTINGS OF 0.2 JOULES AND 50 HERTZ. DURING PROCEDURE, THE LASER FIBER STOPPED WORKING. WHEN THE PHYSICIAN WENT TO UNPLUG, THE FIBER CONNECTOR WAS VERY HOT TO TOUCH. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA HIGH POWER SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162152 ↗
• MalfunctionFeb 24, 2022Break; Misfire; Material Integrity Problem; Break; Misfire; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA LASER FIBER WAS USED IN THE KIDNEY FOR A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER BROKE AND BURNED A HOLE THROUGH THE CHANNEL OF THE SCOPE. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THERE WAS NO BURN INJURY TO THE OPERATOR OR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595403 ↗
• MalfunctionDec 27, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021 . THE LASER UNIT USED WAS A MOSES P120 LASER CONSOLE. DURING THE PROCEDURE, THERE WAS CRACKLED SOUND HEARD FROM THE LASER FIBER CONNECTOR AND IT BECAME HOT. THERE WAS NO BURN INJURY TO THE OPERATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 200 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087533 ↗
• MalfunctionNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 26, 2021 THAT A FLEXIVA ID 200 LASER FIBER WAS TO BE USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER TIP WAS NOTED BROKEN UPON OPENING THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819863 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A LITHOPAXY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS LASER CONSOLE. DURING THE PROCEDURE, IN THE INITIAL FIRING THE LASER FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594953 ↗
• MalfunctionOct 7, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER HAS MALFUNCTIONED, AND REPEATEDLY GAVE AN ERROR MESSAGE THAT THE LASER FIBER NEEDS TO BE ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594915 ↗
• MalfunctionOct 7, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 365 LASER FIBER WAS USED IN A LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING PREPARATION, THE LASER FIBER DID NOT TURN ON. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594880 ↗
• MalfunctionSep 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-04901 FOR THE FIRST FLEXIVA ID 1000 LASER FIBER AND MFR REPORT #3005099803-2021-04922 FOR THE SECOND FLEXIVA ID 1000 LASER FIBER . IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A BLADDER STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF. A SECOND LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. THE TIPS BROKE OFF OUTSIDE THE PATIENT AND THE FIBERS WERE NOT STRIPPED OR CLEAVED BEFORE THEY BROKE. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523520 ↗
• MalfunctionSep 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT #3005099803-2021-04901 FOR THE FIRST FLEXIVA ID 1000 LASER FIBER AND MFR REPORT #3005099803-2021-04922 FOR THE SECOND FLEXIVA ID 1000 LASER FIBER . IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 1, 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A BLADDER STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF. A SECOND LASER FIBER WAS USED AND THE SAME ISSUE OCCURRED. THE TIPS BROKE OFF OUTSIDE THE PATIENT AND THE FIBERS WERE NOT STRIPPED OR CLEAVED BEFORE THEY BROKE. THE PROCEDURE WAS COMPLETED WITH A THIRD FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523510 ↗

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