Percuflex™ Plus M0061752720Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729056836), received between Feb 6, 2024 and Mar 6, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS DISCOVERED THAT THE PART OF THE PIGTAIL COIL WAS DETACHED, AND THE TIP OF THE STENT WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX PLUS STENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540018 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD RECURRENT ABDOMINAL PAIN AND PRESENTED WITH SEVERE PAIN IN THE BLADDER AREA AFTER URINATION. A MEDICATION OF ANALGESIC WAS GIVEN; HOWEVER, IT DID NOT MEET THE PATIENTS SATISFACTORY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF DIFFERENT DEVICE AND THE PATIENT CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: Abdominal Pain; Discomfort

  MAUDE report 20413283 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT, DURING PREPARATION FOR A LITHOTRIPSY PROCEDURE A PERCUFLEX PLUS URETERAL STENT WAS USED, IT WAS NOTICED THE STENT WAS BROKEN OFF. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988411 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT, DURING PREPARATION FOR A LITHOTRIPSY PROCEDURE A PERCUFLEX PLUS URETERAL STENT WAS USED, IT WAS NOTICED THE STENT WAS BROKEN OFF. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT# 2124215-2024-50426).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987528 ↗
• MalfunctionFeb 6, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT HAS A FEW RIDGES THAT MAKE IT DIFFICULT TO PUSH SAFELY INTO THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX PLUS URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655913 ↗