Extractor™ Pro RX-S M00547310Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729907152), received between Jan 4, 2019 and Jul 21, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER OF THE DEVICE BROKE INTO TWO SEPARATE PIECES AS THE PHYSICIAN WAS SWEEPING THE DUCT. IT WAS REPORTED THAT NO PIECE OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. 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 22560069 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CATHETER ON WHICH THE BALLOON IS MOUNTED HAS FAILED. THE BALLOON WAS ATTEMPTED TO BE TAKEN OUT; HOWEVER, IT WAS IMPOSSIBLE TO TAKE IT OUT AS IF SOMETHING WAS STUCK. THERE WAS NO ERECTOR SET UP WHEN THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14934500 ↗
• MalfunctionJun 14, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE CATHETER WAS BROKEN IN TWO SECTIONS; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700172 ↗
• MalfunctionJan 22, 2019Detachment 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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL TIP OF THE CATHETER INCLUDING THE BALLOON DETACHED DURING STONE EXTRACTION. REPORTEDLY, THE DETACHED PART WAS RETRIEVED USING A GRASPING DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON DEVICE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8268300 ↗
• MalfunctionJan 4, 2019Break; 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 THE TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS WERE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS SEVERED AND WAS SECTIONED INTO TWO. THE SAME ISSUE OCCURRED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. IT WAS NOTED THAT NOTHING DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8218018 ↗
• MalfunctionJan 4, 2019Break; 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 THE TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS WERE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS SEVERED AND WAS SECTIONED INTO TWO. THE SAME ISSUE OCCURRED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. IT WAS NOTED THAT NOTHING DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8217978 ↗