Extractor Pro RXRecalls & reported problems across all models

We found 6 models of Extractor Pro RX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2017 and Sep 29, 2026 — classified as 2 deaths, 19 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Break” (35 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Extractor Pro RX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 28, 2025Open, Classified

   The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

   Z-2618-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported Extractor Pro RX problems

Extractor Pro RX models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Extractor™ Pro RX M00547000

  CATHETER, BILIARY, DIAGNOSTIC
  1 recall1 death76 reports
• Extractor™ Pro RX M00547030

  CATHETER, BILIARY, DIAGNOSTIC
  1 recall1 report
• Extractor™ Pro RX M00547010

  CATHETER, BILIARY, DIAGNOSTIC
  1 death39 reports
• Extractor™ Pro RX M00547020

  CATHETER, BILIARY, DIAGNOSTIC
  16 reports
• Extractor™ Pro RX M00547050

  CATHETER, BILIARY, DIAGNOSTIC
  8 reports
• Extractor™ Pro RX M00547040

  CATHETER, BILIARY, DIAGNOSTIC
  1 report

Recent Extractor Pro RX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937591 ↗
• MalfunctionSep 21, 2026Burst Container or Vessel; Inflation Problem; Use of Device Problem; Failure to Deflate

  It was reported to Boston Scientific Corporation that an Extractor Pro RX Retrieval Balloon was attempted to be used during a Cholangiogram procedure to treat gall stones performed on (b)(6) 2026.During the procedure, it was reported that the physician and nurses were unable to deflate device. It was reported that they overfilled in order to pop balloon to extract it. The procedure was completed with another of the same 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: It was reported that, they overfilled in order to pop balloon to extract it. However, per the Instruction for Use (IFU): Inflate the balloon to the appropriate size indicated for the device. Do not exceed the maximum balloon diameter as indicated on the enclosed pre-staked syringe when inflated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835105 ↗
• MalfunctionAug 28, 2026Difficult to Advance; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488968 ↗
• MalfunctionJun 18, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOONS WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STONE REMOVAL IN COMMON BILE DUCT PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE DUCT WAS SWEPT AND DEBRIS WAS REMOVED. UPON WITHDRAWAL OF THE BALLOON CATHETER, THE DISTAL TIP OF THE CATHETER DETACHED AND WAS LEFT IN THE DUODENUM. THE BALLOON ITSELF REMAINED INTACT AND DID NOT SEPARATE INTO THE PATIENT. THE PHYSICIAN WAS NOT USING A GUIDEWIRE DURING THE PROCEDURE, AND IT APPEARS THE CATHETER TIP BENT AND SUBSEQUENTLY BROKE. THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25553583 ↗
• MalfunctionMay 14, 2026Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  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 STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE EXTRACTOR BALLOON SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CATHETER WAS DETACHED OR SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178435 ↗
• DeathApr 7, 2026Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO AN EXTRACTOR PRO RETRIEVAL BALLOON AND WALLFLEX BILIARY STENTS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT METASTATIC PANCREATIC CANCER AND COMMON BILE DUCT OBSTRUCTION PERFORMED ON (B)(6) 2026. POST PROCEDURE, 6 MONTHS AFTER STENT IMPLANTATION, A PARTIALLY COVERED METAL BILIARY STENT WAS REPORTED TO HAVE BEEN OCCLUDED. DURING AN ERCP PERFORMED FOR AN OCCLUDED PANCREATIC CANCER RELATED BILIARY METAL STENT, AN EXTRACTOR BALLOON WAS USED TO SWEEP OBSTRUCTING SLUDGE FROM THE DUCT, AND IT WAS SUSPECTED THAT SIMPLY SWEEPING THE DUCT LED TO A DISLODGING OF A CLOT, WHICH RESULTED IN BLEEDING. SPYGLASS VISUALIZATION REVEALED A PULSATILE BLEEDING SITE LOCATED A CM OR TWO ABOVE THE PROXIMAL END OF THE STENT CONCERNING FOR VASCULAR EROSION. MULTIPLE HEMOSTATIC MEASURES WERE ATTEMPTED, INCLUDING USE OF A HURRICANE BALLOON, EPINEPHRINE INJECTION, AND PLACEMENT OF A FULLY COVERED METAL STENT. DESPITE THESE EFFORTS, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, REQUIRED

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Reduced Blood Flow

  MAUDE report 24809037 ↗
• MalfunctionApr 1, 2026Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE PROCEDURE FOR CBD STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS NOTICED TO BE BROKEN. 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. 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 24761376 ↗
• MalfunctionMar 11, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX WAS PREPARED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PREPARATION, THE CUSTOMER REPORTED SEEING A SMALL DARK HAIR INSIDE THE TRANSPARENT PACKAGING, APPEARING AS A FOREIGN BODY WITHIN THE STERILE DEVICE PACKAGE. 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 24576000 ↗
• InjuryDec 8, 2025Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES AND INDETERMINATE STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER SEVERAL PASSES AND RETRIEVAL ATTEMPTS, THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE DUCT, LIKELY LODGED BETWEEN THE STONE, STRICTURE, AND DUCT WALL. DESPITE APPLYING SIGNIFICANT TRACTION, THE CATHETER COULD NOT BE REMOVED. THE CATHETER WAS CUT OUTSIDE THE SCOPE TO WITHDRAW THE SCOPE, THEN REINTRODUCED THE SCOPE AND TRIMMED THE CATHETER WITHIN THE DUODENUM, LEAVING ONLY A MINIMAL PORTION PROTRUDING FROM THE COMMON BILE DUCT. AFTER THE FINAL CUT, THE DISTAL TIP DISLODGED AND FLOATED ABOVE THE STRICTURE. ATTEMPTS TO RETRIEVE THE TIP USING STRICTURE DILATION VIA SPYGLASS DS, AND SPYBITE MAX WERE UNSUCCESSFUL BECAUSE THE COMMON BILE DUCT WAS TOO DILATED AND THE TIP WAS FLOATING AROUND TOO MUCH. CONSEQUENTLY, A 10X60 WALLFLEX FULLY COVERED STENT WAS PLACED TO OPEN UP THE STRICTURE AND POSSIBLY HAVE THE TIP OF THE CATHETER FALL THROUGH THE STENT AND OUT OF THE DUCT. THERE WER

  Patient problems: Foreign Body In Patient

  MAUDE report 23752441 ↗
• InjuryOct 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS DILATED WITH CONTRAST AND BALLOON BEGAN LEAKING SHORTLY AFTER BEING DILATED. IT WAS REPORTED THAT A SERIOUS INJURY THAT REQUIRED INTERVENTION OCCURRED. ADDITIONAL CLARIFICATION REGARDING THE NATURE OF THE SERIOUS INJURY OR THE TYPE OF REQUIRED INTERVENTION WAS NOT PROVIDED. NO FURTHER INFORMATION IS ABLE TO BE OBTAINED AS THE HEALTHCARE FACILITY AND INITIAL REPORTER WAS NOT REPORTED ON THE MEDWATCH FORM AND IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23364439 ↗
• 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 22708816 ↗

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