Extractor™ Pro XL M00547100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729790389), received between Sep 18, 2017 and Jul 7, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS BEING PREPARED FOR A PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT A FOREIGN OBJECT (HAIR) WAS FOUND IN THE BAG. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742878 ↗
• MalfunctionOct 30, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS BEING PREPARED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONE TO BE PERFORMED ON (B)(6) 2025. DURING PREPARATION, IT WAS NOTICED THAT THE PACKAGING SEAL WAS DAMAGED AND COMPROMISED. THERE WAS NO DEVICE MALFUNCTION NOTED. ADDITIONALLY, A PHOTO OF THE PACKAGING WAS PROVIDED AND SHOWED THAT THE STERILE PACKAGING SEAL WAS NOT SEALED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433217 ↗
• MalfunctionJan 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR PRO XL RETRIEVAL BALLOONS RECEIVED BY THE CUSTOMER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXTRACTOR PRO XL RETRIEVAL BALLOONS WERE RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF THE DEVICE. A PHOTO OF THE DEVICE PACKAGING WAS PROVIDED BY THE CUSTOMER AND SHOWS THAT THE STERILE POUCH HAD A HAIR PRESENT INSIDE THE PACKAGING. THE SAME PROBLEM OCCURRED WITH THE SECOND EXTRACTOR PRO XL RETRIEVAL BALLOON. THESE PRODUCTS WERE NOT USED IN A PROCEDURE. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610490 ↗
• MalfunctionJan 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR PRO XL RETRIEVAL BALLOONS RECEIVED BY THE CUSTOMER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXTRACTOR PRO XL RETRIEVAL BALLOONS WERE RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF THE DEVICE. A PHOTO OF THE DEVICE PACKAGING WAS PROVIDED BY THE CUSTOMER AND SHOWS THAT THE STERILE POUCH HAD A HAIR PRESENT INSIDE THE PACKAGING. THE SAME PROBLEM OCCURRED WITH THE SECOND EXTRACTOR PRO XL RETRIEVAL BALLOON. THESE PRODUCTS WERE NOT USED IN A PROCEDURE. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610488 ↗
• InjuryJul 26, 2023Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON DID NOT DEFLATE. THE PHYSICIAN USED FORCE TO TRY TO REMOVE THE DEVICE FROM THE BILE DUCT. AS A RESULT OF THE STRUGGLE, THE CATHETER KINKED AND THE PATIENT WAS TAKEN TO SURGERY. THE PHYSICIAN ONLY HAD TO VACUUM THE DUCT AND HE WAS ABLE TO REMOVE THE DEVICE EASILY. IN SURGERY, THE PHYSICIAN FOUND A MICROPERFORATION IN THE BILE DUCT BECAUSE BILE WAS NOTED IN THE PERITONEUM. THIS DID NOT REQUIRE ANY SUTURE OR ADDITIONAL TREATMENT BECAUSE IT WAS A VERY SMALL LEAK. THE PATIENT WAS NOTED TO HAVE ST SEGMENT ELEVATION. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED AND FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 17398817 ↗
• MalfunctionFeb 3, 2022Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS PREPARED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND GALLSTONE REMOVAL PROCEDURE TO BE PERFORMED ON (B)(6) 2022. DURING PREPARATION OF THE DEVICE, THE IRRIGATION CANAL WAS TESTED WITH A PHYSIOLOGICAL SOLUTION AND THE SOLUTION CAME THROUGH A FISSURE IN THE CANAL. A REPLACEMENT DEVICE WAS NOT AVAILABLE. THE PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED IN (B)(6) 2022. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443587 ↗
• MalfunctionApr 7, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS NOT A NORMAL SHAPE, AS THE BOTTOM HALF PART OF THE BALLOON HAD A BUBBLE. THERE WAS ALSO DIFFICULTY EXPERIENCED IN REMOVING THE GUIDEWIRE FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629890 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE MAIN BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020 AS PART OF THE (B)(6) STUDY. THE ERCP PROCEDURE WAS PERFORMED WHICH INCLUDED BILIARY SPHINCTEROTOMY AND CANNULATION OF THE MAIN BILE DUCT. ON THE SAME DAY, THE PATIENT EXPERIENCED EPIGASTRIC ABDOMINAL PAIN AND NAUSEA OF MODERATE SEVERITY. THE PATIENT WAS GIVEN A MORPHINE 2MG IV PUSH AND ONDANSETRON 4MG IV PUSH. THE PATIENT WAS NOTED TO BE RECOVERING FOLLOWING THE TREATMENT. IN THE PHYSICIAN'S ASSESSMENT, THERE IS NO RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE EXALT SCOPE, A PROBABLE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE PROCEDURE, AND A POSSIBLE RELATIONSHIPS BETWEEN THE ADVERSE EVENT AND THE EXTRACTOR BALLOON. THERE WAS NO REPORTED MALFUNCTION OR DEFICIENCY OF THE EXTRACTOR BALLOON. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Abdominal Pain; Nausea

  MAUDE report 9774688 ↗
• MalfunctionOct 24, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE EXTRACTOR DEVICE BECAME STUCK. THE DEVICE WAS CONTINUED TO BE PULLED, AND THE CATHETER ULTIMATELY BROKE. IT WAS ALSO NOTED THAT THE COATING OF THE GUIDEWIRE HAD SHEARED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001625 ↗
• MalfunctionSep 18, 2017Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DUODENUM IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THE CATHETER WAS FRAYED AT THE END. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6871764 ↗