Extractor™ Pro RX-S M00547300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729907138), received between Feb 10, 2020 and Mar 25, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE BILE DUCTS DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A BALLOON CATHETER WAS DAMAGED WITHIN THE BILE DUCTS, LEAVING A FRAGMENT RETAINED IN THE ANATOMY. THE PHYSICIAN ATTEMPTED RETRIEVAL, BUT THE FRAGMENT COULD NOT BE REMOVED. A STENT WAS PLACED, PENDING FURTHER INTERVENTION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24693995 ↗
• MalfunctionMar 4, 2026

  FROM STAFF: PATIENT WAS SCHEDULED FOR AN ECRP WITH POSSIBLE STENT PLACEMENT. PROVIDER WAS CAUTERIZING AND DILATION TO THE AMPULLA. EXTRACTOR PRO DILATION BALLOON IN THE DUCT WAS NOT INFLATING PROPERLY. THE TUBING WAS LEAKING AT THE PROXIMAL END TO THE BALLOON. EXTRACTOR REMOVED AND REPLACED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505687 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER CRACKED/BROKE WHEN USING THE EXTRACTOR PRO RX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708824 ↗
• MalfunctionJul 25, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN USING THE BALLOON TO REMOVE A STONE, IT WOULDN'T DEFLATE. IT WAS REPORTED THAT THEY TRIED TO DEFLATE IT WITH THE SYRINGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613004 ↗
• MalfunctionMar 4, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER SNAPPED WHEN THE PHYSICIAN WAS PULLING THE BALLOON OUT OF THE DUCT. THE CUSTOMER STATED THAT NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. THE SAME PROBLEM OCCURRED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832517 ↗
• MalfunctionMar 4, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER SNAPPED WHEN THE PHYSICIAN WAS PULLING THE BALLOON OUT OF THE DUCT. THE CUSTOMER STATED THAT NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. THE SAME PROBLEM OCCURRED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832229 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TIP OF THE BALLOON CATHETER BROKE JUST BELOW THE BALLOON AND WAS STUCK INSIDE THE BILE DUCT. THE PHYSICIAN SWEPT THE DETACHED TIP AND BALLOON OUT OF THE BILE DUCT USING ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON AND 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 17032527 ↗
• MalfunctionMay 25, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXTRACTOR PRO RX-S RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT COMPLETELY DEFLATE EVEN WHEN THE SYRINGE WAS MOVED ALL THE WAY BACK. REPORTEDLY, THE SYRINGE WAS REMOVED AND REFILLED. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877623 ↗
• MalfunctionOct 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON DEVICE WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS WITHDRAWN FROM THE PATIENT, IT WAS NOTICED THAT THE TIP OF THE CATHETER DETACHED INTO THE SCOPE. REPORTEDLY, THE SCOPE WAS THEN REMOVED FROM THE PATIENT AND THE DETACHED TIP WAS PUSHED OUT OF THE WORKING CHANNEL USING A RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10662264 ↗
• MalfunctionFeb 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON DEVICE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE BALLOON BROKE OFF IN THE PANCREAS OF THE PATIENT. REPORTEDLY, THERE WAS AN ATTEMPT TO RETRIEVE THE DETACHED TIP USING ANOTHER BALLOON BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS THEN COMPLETED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687794 ↗