NA M0067201010Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729752998), received between Dec 13, 2017 and Sep 17, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A SINGLE ACTION PUMP SYSTEM WAS ABOUT TO BE USED IN A PROCEDURE. REPORTEDLY, PRIOR TO PROCEDURE IT WAS NOTED THAT A SMALL CONTAMINANT WAS FOUND INSIDE. THE DEVICE WAS NOT USED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072406 ↗
• InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THE STUDY PUBLISHED IN THE INTERNATIONAL BRAZILIAN JOURNAL OF UROLOGY AIMED TO IDENTIFY PERIOPERATIVE PREDICTORS OF IMMEDIATE PAIN FOLLOWING URETEROSCOPY, WITH A SPECIFIC FOCUS ON WHETHER HYDRODISTENTION (FROM PRESSURIZED IRRIGATION) OF THE RENAL COLLECTING SYSTEM CONTRIBUTES TO POST-PROCEDURE PAIN, WHERE AN IRRIGATION SYRING UNIT WAS USED. A TOTAL OF 131 PATIENTS WERE INCLUDED IN THE STUDY WHO UNDERWENT URETEROSCOPY FOR STONE TREATMENT, WITH EQUAL GENDER DISTRIBUTION. AN UNSPECIFIED AMOUNT OF PATIENT EXPERIENCED PAIN THAT REQUIRED NARCOTICS UPON POST-ANESTHESIA CARE UNIT.

  Patient problems: Pain

  MAUDE report 21194246 ↗
• InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN JOURNAL OF ENDOUROLOGY THAT A STUDY WAS CONDUCTED TO EVALUATE THE EFFICACY OF ENDOSCOPIC COMBINED INTRARENAL SURGERY IN THE PRONE SPLIT-LEG POSITION FOR STAGHORN CALCULI. THIS RETROSPECTIVE STUDY ANALYZED THE RECORDS OF 42 PATIENTS WITH STAGHORN CALCULI TREATED WITH ENDOSCOPIC COMBINED INTRARENAL SURGERY (ECIRS) AT A SINGLE CENTER BETWEEN (B)(6) 2010 AND (B)(6) 2013. ENDOSCOPIC COMBINED INTRARENAL SURGERY (ECIRS) INVOLVED SIMULTANEOUS PROCEDURES BY TWO UROLOGISTS, FLEXIBLE URETEROSCOPY WITH A LASER FIBER VIA A URETERAL ACCESS SHEATH AND LITHOCLAST LITHOTRIPSY THROUGH A MINI-PERCUTANEOUS TRACT, PERFORMED IN THE PRONE SPLIT-LEG POSITION. THESE PROCEDURES INVOLVED A IRRIGATION SYRINGE. WITHIN THE REPORTED COMPLICATIONS, ONE PATIENT EXPERIENCED UREHTERAL INJURY, THREE EXPERIENCED URINARY TRACT PERFORATION AND FOUR HAD FEVER. ADDITIONALLY, ONE PATIENT REQUIRED BLOOD TRANSFUSION.

  Patient problems: Fever; Perforation

  MAUDE report 21191588 ↗
• MalfunctionJul 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A TRANSURETHRAL URINARY TRACT STONE REMOVAL PROCEDURE, A SINGLE ACTION PUMP WAS SETUP, AND A PIECE OF VINYL WAS FOUND IN THE LUMEN OF THE SEALED SYRINGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744117 ↗
• MalfunctionJan 3, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMP WAS TO BE USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED, AND THEY FOUND HAIR IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SINGLE ACTION PUMP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436955 ↗
• MalfunctionOct 7, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMPING SYSTEM DEVICE WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE BODY OF THE SYRINGE GOT BROKEN AND A BROKEN PART GOT STUCK INSIDE THE SYRINGE. IT WAS REPORTED THAT THE PHYSICIAN GOT HURT BY THE BROKEN EDGE OF THE SYRINGE AND WAS TREATED WITH BANDAGE COMPRESSION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PHYSICIAN'S CURRENT CONDITION WAS REPORTED TO BE GOOD WITH NO COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15561474 ↗
• MalfunctionJul 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMPING SYSTEM WAS TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. PRIOR TO UNPACKING, IT WAS NOTICED THAT A SMALL REDDISH BROWN SPOTS WERE ATTACHED TO THE ENTIRE CIRCUMFERENCE OF THE SPIKE PART OR THE INSIDE OF THE SPIKE CAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SINGLE ACTION PUMPING SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120907 ↗
• MalfunctionSep 20, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMP WAS INTENDED TO BE USED IN THE UPPER URINARY TRACT IN A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION OUTSIDE THE PATIENT, WHEN THEY TRIED TO OPEN THE INDIVIDUAL PACKAGING OF SINGLE ACTION PUMP SYSTEM (SAPS), IT WAS NOTICED THAT THERE WAS A SMALL BROWN FOREIGN SUBSTANCE INSIDE THE PACKAGING OF THE DEVICE AND SO THEY DECIDED NOT TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SINGLE ACTION PUMP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER SHOWING A SMALL BROWN SUBSTANCE INSIDE THE PACKAGING OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495029 ↗
• MalfunctionJul 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMP WAS UNPACKED TO BE USED IN THE URETER OR THE RENAL PELVIS FOR A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. PRIOR TO THE PROCEDURE, A FOREIGN MATTER WAS NOTED MIXED IN THE STERILIZED BAG. THE PROCEDURE WAS COMPLETED WITH ANOTHER SINGLE ACTION PUMP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249340 ↗
• MalfunctionJan 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMP WAS UNPACKED FOR A URETHRAL STONE CRUSHING PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, PRIOR TO THE DEVICE PACKAGING BEING OPENED, A PIECE OF PAPER WAS FOUND IN THE BAG. THE PROCEDURE WAS COMPLETED WITH ANOTHER SINGLE ACTION PUMP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11236820 ↗
• MalfunctionNov 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMP SYSTEM WAS UNPACKED FOR A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT A HAIR WAS INCLUDED IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SINGLE ACTION PUMP SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS UNPACKED FOR A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE TO BE USED IN THE URETHRA. ADDITIONALLY, THERE WAS NO DAMAGE NOTED IN THE DEVICE PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10851207 ↗
• MalfunctionMar 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMP SYSTEM WAS UNPACKED FOR A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A BLACK LIKE DEPOSIT THAT SEEMED TO BE A DIRT WAS NOTED IN THE PROTECTIVE COVER OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SINGLE ACTION PUMP SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400229 ↗
• MalfunctionNov 13, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMPING SYSTEM (SAPS) WAS UNPACKED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, WHILE UNPACKING, A HAIR LIKE OBJECT WAS FOUND INSIDE THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAPS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8064105 ↗
• MalfunctionDec 13, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMPING SYSTEM (SAPS) WAS UNPACKED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A PEN WAS FOUND INSIDE THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAPS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. REGARDING THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE, IT WAS NOTED THAT THERE WERE NO ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112022 ↗