NA M0067201000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729752981), received between Jun 22, 2020 and Feb 23, 2026 — classified as 1 injury, 5 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A SINGLE ACTION PUMP WAS SET TO BE USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT A HAIR WAS INSIDE THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420864 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE ACTION PUMP WAS USED DURING A CYSTOURETHROSCOPY WITH URETEROSCOPY; WITH TREATMENT OF URETERAL STRICTURE PROCEDURE PERFORMED ON (B)(6) 2017, TO TREAT A PATIENT WITH CALCULUS OF URETER. DURING THE PROCEDURE, THE PATIENT'S URETER WAS LACERATED. THE PATIENT WAS DISCHARGED ONE (1) DAY POST-PROCEDURE.

  Patient problems: Laceration(s)

  MAUDE report 19593948 ↗
• MalfunctionNov 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNOPENED SINGLE ACTION PUMP DEVICE WAS CHECKED DURING STOCKING OR INVENTORY ON (B)(6) 2021. DURING STOCKING OR INVENTORY, A HAIR WAS NOTED INSIDE THE PACKAGE. REPORTEDLY, THERE WAS NO DAMAGE TO THE PACKAGING AND THE STERILE SEALS WERE INTACT. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777663 ↗
• MalfunctionJun 22, 2020Filling Problem; Appropriate Device Problem Term/Code Not Available; Filling Problem; Appropriate Device Problem Term/Code Not Available

  THIS REPORT PERTAINS TO ONE OF THREE SINGLE ACTION PUMPING SYSTEM USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE SINGLE ACTION PUMPING SYSTEMS WERE USED IN THE KIDNEY DURING UTEROSCOPY WITH LASER PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PLUNGER DID NOT DRAW BACK FLUID CAUSING LOSS OF VISIBILITY OF THE TARGET SITE. REPORTEDLY, THE INTENDED PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT WAS STENTED TO COMPLETE THE CASE. ADDITIONALLY, THE PATIENT WILL HAVE TO RETURN FOR TREATMENT AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178341 ↗
• MalfunctionJun 22, 2020Filling Problem; Appropriate Device Problem Term/Code Not Available; Filling Problem; Appropriate Device Problem Term/Code Not Available

  THIS REPORT PERTAINS TO ONE OF THREE SINGLE ACTION PUMPING SYSTEM USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE SINGLE ACTION PUMPING SYSTEMS WERE USED IN THE KIDNEY DURING UTEROSCOPY WITH LASER PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PLUNGER DID NOT DRAW BACK FLUID CAUSING LOSS OF VISIBILITY OF THE TARGET SITE. REPORTEDLY, THE INTENDED PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT WAS STENTED TO COMPLETE THE CASE. ADDITIONALLY, THE PATIENT WILL HAVE TO RETURN FOR TREATMENT AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178339 ↗
• MalfunctionJun 22, 2020Filling Problem; Appropriate Device Problem Term/Code Not Available; Filling Problem; Appropriate Device Problem Term/Code Not Available

  THIS REPORT PERTAINS TO ONE OF THREE SINGLE ACTION PUMPING SYSTEM USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE SINGLE ACTION PUMPING SYSTEMS WERE USED IN THE KIDNEY DURING UTEROSCOPY WITH LASER PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PLUNGER DID NOT DRAW BACK FLUID CAUSING LOSS OF VISIBILITY OF THE TARGET SITE. REPORTEDLY, THE INTENDED PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT WAS STENTED TO COMPLETE THE CASE. ADDITIONALLY, THE PATIENT WILL HAVE TO RETURN FOR TREATMENT AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178338 ↗