SlimLine™ SlimLine™ SIS EZ 550Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 07290109145662), received between Feb 15, 2023 and Sep 21, 2026 — classified as 19 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Break” (61 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848668 ↗
• MalfunctionSep 21, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848628 ↗
• MalfunctionMar 30, 2026Nonstandard Device; Connection Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE DID NOT RECOGNIZE THE FIBER. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE FIBER TIP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730493 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT THE FIBER BROKE IN THE MIDDLE OF THE PROCEDURE, RESULTING IN A SHORTENED FIBER. THE FIBER WAS IMMEDIATELY REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24371534 ↗
• MalfunctionFeb 3, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT THE FIBER FRACTURED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250669 ↗
• MalfunctionJan 22, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE FIBER FRACTURED. AFTER REPLACING IT, THE PROCEDURE CONTINUED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146722 ↗
• MalfunctionJan 22, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE FIBER FRACTURED. AFTER REPLACING IT, THE PROCEDURE CONTINUED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146716 ↗
• MalfunctionJan 22, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE FIBER FRACTURED. AFTER REPLACING IT, THE PROCEDURE CONTINUED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146708 ↗
• MalfunctionJan 13, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING PREPARATION OF THE PROCEDURE, THE FIBER BURNED OUT AND DAMAGED THE DEBRIS SHIELD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURED CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064022 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT TWO FIBERS WERE NOT WORKING AS EXPECTED. THERE WAS A SPARK AS SOON AS THE CONSOLE WAS STARTED, ACCOMPANIED BY AN UNUSUAL NOISE. TWO OTHER FIBERS FROM THE SAME LOT WERE USED TO COMPLETE THE PROCEDURES, AND THEY WORKED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS COMPLAINT REFERS TO THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986644 ↗
• MalfunctionJan 6, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT TWO FIBERS WERE NOT WORKING AS EXPECTED. THERE WAS A SPARK AS SOON AS THE CONSOLE WAS STARTED, ACCOMPANIED BY AN UNUSUAL NOISE. TWO OTHER FIBERS FROM THE SAME LOT WERE USED TO COMPLETE THE PROCEDURES, AND THEY WORKED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS COMPLAINT REFERS TO THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986577 ↗
• InjuryNov 28, 2025Break; Gas Output Problem; Break; Gas Output Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE USER IDENTIFIED THAT THE LASER POWER IS NOT TRANSMITTED AS WELL THROUGH SINGLE-USE FIBERS, MAKING DISSECTION MORE COMPLICATED. IN ADDITION, INSERTING THE PROBE INTO THE ANCILLARY LOOP IS MORE COMPLICATED DUE TO FRICTION. ALSO, DURING USE THE PROBE BROKE CLEANLY, CAUSING A BURN TO THE USER'S RIGHT INDEX FINGER. THE DEVICE WAS REPLACED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 23671766 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE FIBER WAS CONNECTED AND THE FOOT PEDAL WAS FIRST PUSHED, THERE WAS A BURNT SMELL IN THE CONNECTION OF THE FIBER TO THE EQUIPMENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304561 ↗
• MalfunctionSep 22, 2025Break; Break

  IT WAS REPORTED THAT THE DEBRIS SHIELD BLEW CAUSING A SLIMLINE FIBER AND A MOSES FIBER TO BREAK IMMEDIATELY AFTER THE FIRST SHOT. THE FIBER AND THE DEBRIS SHIELD WERE REPLACED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS REPORT REFERS TO THE SLIMLINE FIBER THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23116607 ↗
• InjurySep 12, 2025Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE DURING THE PROCEDURE AND TOUCHED THE PHYSICIAN'S ARM, WHO FELT AN ELECTRIC SHOCK SINCE IT WAS ACTIVATING THE LASER AND SUFFERED A BURN. THE PHYSICIAN DID NOT RECEIVE ANY TREATMENT FOR THE BURN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Burn(s); Electric Shock

  MAUDE report 23037391 ↗
• MalfunctionAug 22, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER WAS NOT FUNCTIONING. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. LABORATORY ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT NO LIGHT WAS EXITING THE CONNECTOR FACE AND NO AIM BEAM EXITING THE FIBER TIP, INDICATIVE OF CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874478 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER SNAPPED. THE FIBER WAS REPLACED BUT THE NEW FIBER ALSO SNAPPED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543425 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT, THE FIBER BROKE DURING HOLMIUM ENUCLEATION OF THE PROSTATE PROCEDURE. THE FIBER WAS REPLACED, AND ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502318 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A HOLMIUM LASER ENUCLEATION OF PROSTATE PROCEDURE, THE FIBER SUDDENLY FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468171 ↗
• InjuryJun 20, 2025Break; Break

  IT WAS REPORTED DURING PROCEDURE, THE FIBER BROKE ON THE PROXIMAL SIDE AND BURNED THE PHYSICIAN. THE BURN WAS IN THE RIGHT HAND AND THERE WAS NOT TREATMENT. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 22299042 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE AT THE POINT OF INSERTION TO THE SCOPE. THE FIBER WAS REPLACED FOR A SECOND TIME; HOWEVER, THE NEW FIBER BROKE AS WELL. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212322 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE AT THE POINT OF INSERTION TO THE SCOPE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212318 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKED AT THE POINT OF INSERTION TO THE SCOPE. THE FIBER WAS REPLACED, HOWEVER, THE NEW FIBER ALSO SNAPPED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212317 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, HALFWAY THROUGH THE PROCEDURE, THE FIBER BROKE IN THE MIDDLE OF THE BODY AND CAUSED A SMALL BURN IN THE COVERINGS. IT WAS NOTED THAT A LUMENIS P120 MOSES 1.0 CONSOLE WITH 2 J 45 HZ SETTINGS, AND A 30 CM, 4 MM, 30 DEGREE STORZ SCOPE WERE USED FOR THE PROCEDURE. A FIBER POLE WAS NOT USED TO KEEP FIBER LENGTH CLEAR OF POTENTIAL KINKS OR BENDS, AND NO PRESSURIZED SALINE IRRIGATION WAS USED. AT THE TIME OF INCIDENT, THE PHYSICIAN FELT SOME WARMTH IN THE ELBOW BUT DID NOT GET BURNT. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF SAME MODEL WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178918 ↗
• MalfunctionMay 7, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING PREPARATION OUTSIDE THE PATIENT OF A PROSTATE ENUCLEATION PROCEDURE, THE FIBER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979258 ↗