Percuflex™ M0061453730Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729040408), received between Apr 19, 2019 and Apr 19, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX STENT WAS TO BE USED FOR A CYSTOSCOPE ROOM FOR BLADDER EXAMINATION AND PLACEMENT OF URETERAL STENT PROCEDURE, TO BE PERFORMED IN THE BLADDER AND URETER ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN PULLING THE SUTURE STRING, THE STENT BROKE ALONG THE SHAFT. THE PROCEDURE WAS CANCELLED AND WAS RESCHEDULED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531610 ↗
• MalfunctionApr 19, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX STENT WAS TO BE USED FOR A CYSTOSCOPE ROOM FOR BLADDER EXAMINATION AND PLACEMENT OF URETERAL STENT PROCEDURE, TO BE PERFORMED IN THE BLADDER AND URETER ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN ALONG THE SHAFT. THE PROCEDURE WAS CANCELLED AND WAS RESCHEDULED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531609 ↗
• MalfunctionApr 19, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX STENT WAS TO BE USED FOR A CYSTOSCOPE ROOM FOR BLADDER EXAMINATION AND PLACEMENT OF URETERAL STENT PROCEDURE, TO BE PERFORMED IN THE BLADDER AND URETER ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN ALONG THE SHAFT. THE PROCEDURE WAS CANCELLED AND WAS RESCHEDULED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531574 ↗