Extractor™ Pro XL M00547150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729790372), received between Feb 26, 2019 and Sep 16, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A BILE DUCT STONE REMOVAL PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE DEFLATION WAS SLOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232545 ↗
• MalfunctionMar 27, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THIS DEVICE WAS USED, A PROBLEM OCCURRED WHERE INFLATION OF THE BALLOON WAS ABLE TO BE PERFORMED BUT DEFLATION WAS DIFFICULT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988453 ↗
• MalfunctionJan 25, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT FOR A BILIARY LITHOTOMY FOR GALLSTONE REMOVAL PROCEDURE PERFORMED ON JANUARY 05, 2023. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED BUT THE BALLOON COULD NOT DEFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240332 ↗
• MalfunctionJan 12, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A GALLSTONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON COULD BE INFLATED; HOWEVER, IT WOULD NOT DEFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152745 ↗
• MalfunctionFeb 26, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING A BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON COULD NOT BE DEFLATED, WHICH CAUSED DIFFICULTY WHEN WITHDRAWING THE CATHETER THROUGH THE ENDOSCOPE. REPORTEDLY, THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY TOGETHER WITH THE ENDOSCOPE. THE PHYSICIAN THEN CUT THE CATHETER WITH SCISSORS AT THE PART WHICH WAS PROTRUDING FROM THE TIP OF THE ENDOSCOPE AND THE BALLOON WAS FOUND TO BE DEFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369915 ↗