Extractor™ Pro XL M00547140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729790365), received between Jul 9, 2020 and Feb 4, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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.

• InjuryFeb 4, 2026Difficult to Remove; Use of Device Problem; 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED TO TREAT STONES ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE COULD NOT BE REMOVED FROM THE BILE DUCT BECAUSE IT COULD NO LONGER BE DEFLATED. EXTENSIVE MANIPULATION WITH MULTIPLE SUCTION SYRINGES, INCLUDING CUTTING THE BALLOON PORT, WAS UNSUCCESSFUL. INTUBATION WAS PERFORMED USING AN ERCP CATHETER AND ADVANCED TO THE POINT WHERE THE BALLOON BECAME BLOCKED. VARIOUS WIRES WERE THEN ADVANCED, BUT THESE DID NOT CAUSE THE BALLOON TO BURST. A NEEDLE KNIFE WAS THEN ATTEMPTED, INCLUDING SHORT ELECTRICAL CURRENT PULSES. THIS ALSO PROVED UNSUCCESSFUL. AS A LAST RESORT, A JAGWIRE WAS USED, AND A REGULAR-SIZE SCIVITA CHOLANGIOSCOPE WAS ADVANCED. ADVANCEMENT TO THE IMPACTED BALLOON CATHETER REVEALED A STONE-LIKE PATTERN IN THE DUCTUS HEPATICUS (DHS). INDIVIDUAL STONES WERE VISUALIZED USING ELECTROCAUTERY UNTIL THE BALLOON WAS SEEN. A SINGLE ELECTROCAUTERY PULSE WAS THEN APPLIED TO THE BALLOON, CAUSING IT TO BURST. THE BALLOON CATHETER WAS THEN REMOVED ORALLY WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264149 ↗
• MalfunctionFeb 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS RECEIVED BY THE CUSTOMER ON (B)(6) 2025. BEFORE THE PROCEDURE, UPON RECEIVING THE PACKAGE, A HAIR WAS FOUND IN THE SEALED PACKAGING OF THE PRODUCT. A PHOTO OF THE DEVICE PACKAGING WAS SUBMITTED BY THE CUSTOMER AND SHOWED A HAIR INSIDE THE SEALED PACKAGE. THE PRODUCT WAS NOT USED IN A PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454726 ↗
• MalfunctionApr 4, 2024Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING A COMMON BILE DUCT LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER UNPACKING THE DEVICE, AIR WAS INTRODUCED, HOWEVER, A RESISTANCE WAS FELT, AND POOR DEFLATION WAS OBSERVED. DESPITE THESE PROBLEMS, THE DEVICE WAS USED CONTINUOUSLY. IT WAS THEN INSERTED INTO THE COMMON BILE DUCT THROUGH AN ENDOSCOPE. WHEN THE BALLOON WAS INFLATED, THE SAME PROBLEM OCCURRED. THE DEVICE WAS REMOVED FROM THE BODY TO HAVE IT CHECKED AND INJECTED A SALINE SOLUTION INTO THE BALLOON LUMEN INSTEAD OF AIR, BUT THE PROBLEM PERSISTED. 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 19042814 ↗
• MalfunctionApr 6, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS UNPACKED FOR A PROCEDURE PERFORMED ON (B)(6) 2021. A 3-4MM PINK THREAD/STRING WAS NOTICED IN THE SEALED PORTION OF THE STERILIZATION BAG. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Insufficient Information

  MAUDE report 11622122 ↗
• MalfunctionJul 9, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS UNPACKED FOR A PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE DEVICE PACKAGING BEING OPENED, A HAIR WAS NOTICED FROM THE OUTSIDE OF THE PACKAGING. IT WAS NOTED THAT THERE WAS NO PHYSICAL DAMAGE ON THE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251705 ↗