Extractor™ Pro XL M00547120Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729790648), received between Nov 1, 2018 and Mar 6, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED DURING A UROLOGICAL ENDOSCOPY PROCEDURE ON (B)(6) 2026. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS NOT DEFLATING PROPERLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL DEVICE. 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 24532364 ↗
• MalfunctionNov 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON DID NOT FULLY INFLATE. FROM ITS CENTER PART, ONLY ONE SIDE OF THE BALLOON INFLATED MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE BALLOON INFLATED TO AN IRREGULAR SHAPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696102 ↗
• InjuryMay 2, 2024Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem

  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 ON (B)(6) 2024. DURING A CHOLANGIOGRAM PROCEDURE TO HELP LOCATE A BLOCKAGE IN THE BILE DUCT, A STONE EXTRACTION BALLOON WAS INFLATED AND THERE WAS "AN INJURY OR LEAK IN THE BILE DUCT." A STENT WAS PLACED IN THE BILE DUCT. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY AND HOSPITALIZED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THE SPECIFIC DEVICE PROBLEM IS UNKNOWN. IT WAS REPORTED THAT "THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." ADDITIONAL INFORMATION RECEIVED ON JUNE 21, 2024: ADDITIONAL INFORMATION WAS RECEIVED THAT THIS EVENT WAS PREVIOUSLY REPORTED. SEE MFR. REPORT #3005099803-2024-00803

  Patient problems: Biliary Leak

  MAUDE report 19233391 ↗
• MalfunctionApr 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE SIZE OF THE BALLOON AND THE SHAPE WAS NOT NORMAL. 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 19043042 ↗
• InjuryMar 5, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WAS OVERINFLATED AND STARTED LEAKING AND WAS REMOVED FROM THE PATIENT. THIS CAUSED A PERFORATION IN THE DUCT WHICH WAS TREATED BY PLACING A PLASTIC STENT. DUE TO THE PERFORATION, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE CUSTOMER REPORTED THAT THE 15 MM BALLOON CHOSEN WAS TOO LARGE FOR THE 3 TO 4 MM DUCT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024, AND THEIR CURRENT CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 18841399 ↗
• MalfunctionJul 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DISTAL COMMON BILE DUCT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS KINKED. 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 17283658 ↗
• MalfunctionJun 28, 2023Material Deformation; Failure to Deflate; Material Deformation; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE GAS COULD NOT BE LET OFF AFTER INFLATING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. CORRECTION: THE CUSTOMER ALSO REPORTED THAT THE BALLOON WAS SEEN BULGING AFTER INFLATION. A PHOTO SUBMITTED BY THE CUSTOMER SHOWS AN IRREGULAR SHAPED INFLATED BALLOON OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218609 ↗
• MalfunctionSep 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILIARY TRACTS FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PREPARATION, THE BALLOON WAS ABLE TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON HAD AN IRREGULAR SHAPE, WHICH WAS CONFIRMED VIA A VIDEO SUBMITTED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451331 ↗
• MalfunctionApr 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN IN TWO SEPARATE PARTS. REPORTEDLY, THE SCOPE WAS REMOVED FROM THE PATIENT AND THE CATHETER WAS CUT IN ORDER TO LET OUT THE AIR FROM THE BALLOON. THE REMAINING PART OF THE DEVICE INCLUDING THE BALLOON WAS THEN PULL OUT FROM THE PATIENT. 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536490 ↗
• MalfunctionMar 20, 2019Device 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 ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, A BLACK PARTICLE WAS NOTICED IN BETWEEN THE PRODUCT BOX AND THE PLASTIC BAG, AND THERE WAS ALSO A BLACK PARTICLE IN THE STICKY PART OF THE SEAL. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING, AND THE STERILE SEAL DID NOT APPEAR TO BE COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. ADDITIONAL INFORMATION RECEIVED ON 17APR2019: UPON RE-CHECKING THE PRODUCT, IT WAS NOTED THAT THERE WAS NO BLACK MATERIAL FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 8437611 ↗
• MalfunctionMar 20, 2019Device 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 ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, A BLACK PARTICLE WAS NOTICED IN BETWEEN THE PRODUCT BOX AND THE PLASTIC BAG, AND THERE WAS ALSO A BLACK PARTICLE IN THE STICKY PART OF THE SEAL. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING, AND THE STERILE SEAL DID NOT APPEAR TO BE COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019*** UPON RE-CHECKING THE PRODUCT, IT WAS NOTED THAT THERE WAS NO BLACK MATERIAL FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 8437605 ↗
• MalfunctionMar 20, 2019Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS UNPACKED ON FEBRUARY 22, 2019. ACCORDING TO THE COMPLAINANT, A BLACK PARTICLE WAS NOTICED IN BETWEEN THE PRODUCT BOX AND THE PLASTIC BAG, AND THERE WAS ALSO A BLACK PARTICLE IN THE STICKY PART OF THE SEAL. THERE WAS ALSO UNSPECIFIED DAMAGE TO THE DEVICE PACKAGING, THOUGH THE STERILE SEAL DID NOT APPEAR TO BE COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. ***ADDITIONAL INFORMATION RECEIVED ON 17APR2019*** BASED ON A PHOTO OF THE DEVICE POUCH SENT BY THE CUSTOMER, THERE WAS A BLACK PARTICLE NOTICED WITHIN THE PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 8437603 ↗
• MalfunctionNov 1, 2018Device 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 ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, IT WAS NOTED THAT A HAIR WAS FOUND INSIDE THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 8029296 ↗