Percuflex™ Plus M006175253080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729297338), received between Feb 24, 2021 and Aug 10, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2022Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING PREPARATION, WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE STENT INTO THE PATIENT, IT COULD NOT BE INSERTED DUE TO THERE WAS NO STIFFNESS AT THE TIP. ANOTHER PERCULFEX PLUS URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199807 ↗
• MalfunctionApr 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PIGTAIL TIP WAS KINKED DURING INSERTION, AND IT WAS NOT POSSIBLE TO INSERT SMOOTHLY. ANOTHER PERCUFLEX PLUS URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138112 ↗
• MalfunctionApr 28, 2021Defective Device; Deformation Due to Compressive Stress; Material Split, Cut or Torn; Defective Device; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING AN UNKNOWN PROCEDURE, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE WHEN THE GUIDEWIRE WAS RELEASED, THE PIGTAIL DID NOT COIL UP PROPERLY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT COIL BUCKLED/ACCORDION AND STENT TORN INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739881 ↗
• MalfunctionFeb 24, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED ON (B)(6) 2021 THAT THE PERCUFLEX PLUS URETERAL STENT WAS NOTICED TO HAVE TEAR IN THE DEVICE PACKAGING SEAL. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375860 ↗