Extractor™ Pro RX M00547020Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729790310), received between Dec 17, 2018 and Oct 15, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT JAUNDICE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON HAD A SLOW DEFLATION PROCESS WHEN THE STONE REMOVAL BALLOON WAS REMOVED FOR THE SECOND TIME, AND IT WAS THE SAME WHEN IT WAS WITHDRAWN AND TESTED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX 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 23287455 ↗
• MalfunctionSep 15, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COLON DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE TO TREAT COLONIC STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TECHNICIAN PREPARED AN EXTRACTOR PRO RX RETRIEVAL BALLOON BY PRIMING AND TESTING IT. THE BALLOON WORKED WHEN TESTED AND THEN BACKLOADED IT OVER THE GUIDEWIRE AND ADVANCED IT THROUGH THE WORKING CHANNEL. THE PHYSICIAN NAVIGATED THE BALLOON ACROSS THE STRICTURE, INITIALLY DEFLATED, THEN INFLATED IT BEYOND THE NARROWING AND INJECTED CONTRAST TO VISUALIZE THE LUMEN UNDER FLUOROSCOPY. UPON ATTEMPTING TO DEFLATE THE BALLOON, THE BALLOON DID NOT NATURALLY DEFLATE WHEN THE STOP COCK WAS TURNED TO DEFLATE THE BALLOON. THE TECHNICIAN HAD TO MANUALLY RETRACT THE PUSHER ON THE INFLATION DEVICE TO ACHIEVE DEFLATION. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 23057944 ↗
• MalfunctionAug 21, 2025Inflation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Inflation 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 COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION OUTSIDE THE PATIENT, IT WAS REPORTED THAT THEY WANT TO USE 15-18 BALLOON, BUT THE OPENING EFFECT WAS NOT GOOD DURING THE TEST OUTSIDE THE BODY OF PATIENT. IT WAS REPORTED THAT THE BALLOON COULD BE INFLATED, BUT IT WON'T OPEN ALL THE WAY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: VIDEO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE BALLOON WAS INFLATED AND SHAPED IRREGULARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865613 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER CRACKED/BROKE WHEN USING THE EXTRACTOR PRO RX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 22708818 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER CRACKED/BROKE WHEN USING THE EXTRACTOR PRO RX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 22708813 ↗
• MalfunctionDec 19, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS BEING PREPARED FOR USED IN THE BILE DUCT DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE BALLOON WAS CHECKED, AND IT WAS FOUND THAT A PART OF THE BALLOON DID NOT DEFLATE DURING DEFLATION AND AIR REMAINED IN THE BALLOON. IT WAS CHECKED IN THE SAME WAY SEVERAL TIMES, BUT THE SAME PROBLEM OCCURRED. 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 20977257 ↗
• MalfunctionSep 2, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE BALLOON WOULD NOT DEFLATE UPON TESTING. IT WAS REPORTED THAT WHEN THE BALLOON WAS DEFLATED USING AN INFLATION DEVICE, THE BALLOON PORTION WAS PARTIALLY "PUFFED UP" AND WHEN THAT PORTION IS HELD DOWN BY HAND, IT WILL BE COMPLETELY DEFLATED. 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 20117958 ↗
• MalfunctionMar 19, 2024Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS VERY STRONG RESISTANCE WHEN THE BALLOON WAS INSERTED INTO THE BILE DUCT. THE BALLOON COULD BE INFLATED WITHOUT ANY PROBLEM, BUT COULD NOT BE DEFLATED, SO IT WAS REMOVED FROM THE BILE DUCT BY FORCE. 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 18937732 ↗
• MalfunctionJul 27, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WOULD NOT INFLATE. THE BALLOON WAS REMOVED FROM THE SCOPE, AND WAS TESTED. IT WAS NOTICED THAT THERE WAS A TEAR NEAR THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CATHETER DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114498 ↗
• MalfunctionMay 26, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON 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 14519218 ↗
• MalfunctionFeb 17, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE INSIDE THE PATIENT BUT WAS ABLE TO BE REMOVED NORMALLY. 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 13548140 ↗
• MalfunctionJan 5, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING A COMMON BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN BALLOON DEFLATION WAS PERFORMED, THE AIR ON ONE SIDE OF THE BALLOON COULD NOT BE REMOVED AND THE BALLOON DID NOT DEFLATE EVENLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172982 ↗
• MalfunctionJun 24, 2021Inflation Problem; Defective Device

  PATIENT WITH HISTORY OF CARDIAC ARREST AND RECENT CHOLEDOCHOLITHIASIS WAS ADMITTED FOR A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, SPHINCTEROTOMY, STONE REMOVAL AND STENT REPLACEMENT. BOSTON SCIENTIFIC EXTRACTOR" PRO RX RETRIEVAL BALLOON CATHETER WAS DIFFICULT TO INFLATE. ONCE IT DID INFLATE, IT LOST AIR. THE EXTRACTOR" PRO RX RETRIEVAL BALLOON CATHETER WAS REMOVED WITHOUT KNOWN HARM TO THE PATIENT, AND ANOTHER DEVICE WAS USED FOR PROCEDURE. UPON EXAMINATION, IT WAS OBSERVED THAT THE CATHETER ABOVE THE BALLOON HAD A SLIT AND WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12056984 ↗
• MalfunctionMar 11, 2021Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE BALLOON WAS PUT DOWN THE WORKING CHANNEL FOR THE SECOND TIME IT WAS NOTICED THAT THE TIP OF THE BALLOON LOOKED DIFFERENT. REPORTEDLY, THE BALLOON COULD NOT BE INFLATED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP OF THE BALLOON COMPLETELY FELL OFF AND WAS LATER FOUND ON THE FLOOR. 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 11464431 ↗
• MalfunctionJun 10, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX 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, THE CATHETER BROKE IN HALF AND DETACHED IN THE COMMON BILE DUCT OF THE PATIENT DURING STONE EXTRACTION. REPORTEDLY, THE ELEVATOR OF THE SCOPE WAS ABLE TO CLOSE ON THE REMAINING PORTION OF THE CATHETER AND THE SCOPE WAS PULLED OUT SUCCESFULLY FROM THE PATIENT INCLUDING THE DISTAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682400 ↗
• MalfunctionDec 17, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICE WAS USED IN THE BILIARY AREA DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE BALLOON WAS TESTED OUTSIDE THE DUODENOSCOPE AND WAS NOTED TO INFLATE ONLY AT ONE SIDE. IT WAS ALSO NOTED THAT THE BALLOON COULD NOT INITIALLY BE DEFLATED; AFTER SEVERAL ATTEMPTS, THE BALLOON DEFLATED. AFTER INTRODUCING THE DEVICE INTO THE SCOPE CHANNEL, THE SAME PROBLEM OCCURRED AGAIN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 19, 2018. IT WAS REPORTED THAT THE EVENT OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8169217 ↗