Extractor™ Pro RX M00547050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729790303), received between Feb 19, 2019 and Jan 30, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS BEING PREPARED FOR USE IN THE CENTRAL BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE BALLOON WAS ATTEMPTED TO BE INFLATED, AS IT USUALLY EXPANDS BY BEING PUSHED TO THE 15 MM POSITION. HOWEVER, THIS TIME IT DID NOT INFLATE AT THE 15 MM POSITION. THEREFORE, IT WAS PUSHED UP TO 18 MM AND THEN PULLED BACK TO THE 15 MM POSITION TO ADJUST ITS SIZE. UNFORTUNATELY, THE SHAPE OF THE BALLOON WAS DISTORTED DURING THE PROCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610489 ↗
• MalfunctionDec 12, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED IN THE BILE DUCT, THE SHAPE WAS DISTORTED, AND THE INFLATION WAS SLOW. THE CUSTOMER REPORTED THAT THE BALLOON WAS BULGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314482 ↗
• MalfunctionAug 2, 2023Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED. HOWEVER, WHEN THE DEVICE WAS CHECKED OUTSIDE OF THE PATIENT, THE BALLOON INFLATES OCCASIONALLY, BUT THE SHAPE WAS FOUND TO BE DISTORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445488 ↗
• MalfunctionJan 11, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS UNABLE TO BE DEFLATED. AFTER TRYING SEVERAL TIMES, THE BALLOON WAS FINALLY ABLE TO DEFLATE, BUT DESPITE THIS, IT WAS STILL DIFFICULT TO MANIPULATE THE BALLOON AND PERFORM FLUOROSCOPY/CONTRAST IMAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. 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 11150941 ↗
• MalfunctionDec 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS RECEIVED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PRODUCT WAS RECEIVED, IT WAS NOTICED THAT THERE WAS A FOREIGN OBJECT THAT COMPROMISED THE STERILITY OF THE DEVICE. A PHOTO SUBMITTED BY THE CUSTOMER CONFIRMS UNKNOWN RESIDUE WITHIN THE PACKAGING. THERE WAS NO REPORTED DAMAGE TO THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11049502 ↗
• MalfunctionApr 30, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS UNPACKED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THERE WAS A SMALL HOLE IN THE PACKAGING THAT SEEMS TO COMPROMISE STERILITY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10014469 ↗
• MalfunctionJun 14, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE DISTAL BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND RESISTANCE WAS FELT NEAR THE TIP OF THE SCOPE WHICH MADE THE DEVICE UNABLE TO PASS THROUGH. CONTINUED ATTEMPTS WERE MADE, BUT RESISTANCE WAS STILL FELT. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THE DEVICE TIP SEEMED TO BE LIFTED AND HAD FINE SLIP. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700093 ↗
• MalfunctionFeb 19, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICE WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THE CATHETER OF THE DEVICE WAS CRACKED IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX 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 8349761 ↗