Percuflex™ M0061453620Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729040330), received between Jun 15, 2018 and Jun 18, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS TO BE USED IN A FLEXIBLE URETEROSCOPIC LITHOTRIPSY AND STONE EXTRACTION WITH POSTOPERATIVE STENT PLACEMENT. DURING UNPACKING IT WAS FOUND THAT THE PACKAGING WAS OPENED AND FOUND TO BE DAMAGED. DUE TO THE COMPROMISED INTEGRITY OF THE PACKAGING, CONTAMINATION OF THE DEVICE WAS SUSPECTED. THE DEVICE WAS THEREFORE DEEMED UNSUITABLE FOR USE AND WAS NOT UTILIZED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552257 ↗
• MalfunctionJun 24, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS ABOUT TO PLACE A URETERAL STENT FOR THE PATIENT, BUT WHEN THE STENT WAS UNPACKAGED, IT WAS FOUND THAT THE URETERAL STENT WAS FRACTURED. THEREFORE, A NEW URETERAL STENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324485 ↗
• MalfunctionJun 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146389 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT AFTER UNPACKING, THE STENT WAS FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981508 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT DURING UNPACKING, THE PHYSICIAN UNPACKED THE DEVICE AND IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PATIENT CONDITION FOLLOWING PROCEDURE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868347 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS TO BE USED IN A URETERAL STENT IMPLANTATION PROCEDURE. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE STENT WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED WITH A NEW STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031248 ↗
• MalfunctionNov 19, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THE KIDNEY STONE SURGERY A PERCUFLEX URETERAL STENT WAS GOING TO BE USED. WHEN THE PHYSICIAN UNPACKED THE DEVICE, IT WAS FOUND THAT THE STENT WAS FRACTURED. ANOTHER URETERAL STENT PACKAGE WAS OPENED, AND IT WAS FRACTURED AGAIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-71116 AND MFR REPORT # 2124215-2024-71119).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20717891 ↗
• MalfunctionNov 18, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THE KIDNEY STONE SURGERY A PERCUFLEX URETERAL STENT WAS GOING TO BE USED. WHEN THE PHYSICIAN UNPACKED THE DEVICE, IT WAS FOUND THAT THE STENT WAS FRACTURED. ANOTHER URETERAL STENT PACKAGE WAS OPENED, AND IT WAS FRACTURED AGAIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT IS ONE OF TWO COMPLAINTS THAT [ERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-71116 AND MFR REPORT #.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716764 ↗
• MalfunctionMay 22, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE CHINESE LABEL WAS DAMAGED. IT WAS NOTED THAT THE DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376840 ↗
• MalfunctionDec 28, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URETERAL STENT WAS OPENED ON (B)(6) 2021. DURING UNPACKING, IT WAS FOUND THAT THE STENT BECAME FRACTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE DISTAL END OF THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064817 ↗
• MalfunctionOct 5, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPEN TO BE USED DURING A URETERAL LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE DEVICE, IT WAS NOTICED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PERCUFLEX PLUS URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627100 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX STENT WAS TO BE USED FOR A URETERAL STENT PLACEMENT PROCEDURE TO BE PERFORMED IN THE URETER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, PRIOR TO INSERTION, THE STENT BROKE IN HALF . THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8178641 ↗
• MalfunctionJun 15, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ STENT WAS USED IN THE URETER FOR A URETERAL HOLMIUM LASER LITHOTRIPSY PROCEDURE PERFORMED IN THE URETER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE STENT COIL DETACHED WHEN THEY WERE PULLING OFF THE REAR LINE OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX¿ STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606311 ↗