Extractor Pro XLRecalls & reported problems across all models
Boston Scientific Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 5 models of Extractor Pro XL by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2017 and Jul 7, 2026 — classified as 6 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (12 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. 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
Reports received per month, all models
Most reported Extractor Pro XL problems
Device problems
- Failure to Deflate12
- Break11
- Device Contaminated During Manufacture or Shipping8
- Material Deformation8
- Device Contamination with Chemical or Other Material5
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem4
- Use of Device Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient13
- No Patient Involvement4
- Perforation3
- Abdominal Pain1
- Biliary Leak1
- Insufficient Information1
- Nausea1
Extractor Pro XL models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Extractor™ Pro XL M00547110CATHETER, BILIARY, DIAGNOSTIC22 reports
- Extractor™ Pro XL M00547120CATHETER, BILIARY, DIAGNOSTIC13 reports
- Extractor™ Pro XL M00547100CATHETER, BILIARY, DIAGNOSTIC10 reports
- Extractor™ Pro XL M00547140CATHETER, BILIARY, DIAGNOSTIC5 reports
- Extractor™ Pro XL M00547150CATHETER, BILIARY, DIAGNOSTIC5 reports
Recent Extractor Pro XL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS BEING PREPARED FOR A PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT A FOREIGN OBJECT (HAIR) WAS FOUND IN THE BAG. THE DEVICE WAS NOT USED, AND 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 25742878 ↗MalfunctionApr 8, 2026Failure to Deflate
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS BEING PREPARED FOR USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILE DUCT STONES TO BE PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE SYRINGE WAS REMOVED FOLLOWING BALLOON INFLATION. HOWEVER, THE BALLOON DID NOT DEFLATE AND REMAINED INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 24823412 ↗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 ↗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 ↗MalfunctionNov 5, 2025Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT PRESENCE OF CALCULI IN THE BILIARY TRACT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AT THE TIME OF EXTRACTING THE GALLSTONE THE BALLOON SPLIT IN TWO. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE CATHETER DETACHED OR SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477442 ↗MalfunctionOct 30, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS BEING PREPARED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONE TO BE PERFORMED ON (B)(6) 2025. DURING PREPARATION, IT WAS NOTICED THAT THE PACKAGING SEAL WAS DAMAGED AND COMPROMISED. THERE WAS NO DEVICE MALFUNCTION NOTED. ADDITIONALLY, A PHOTO OF THE PACKAGING WAS PROVIDED AND SHOWED THAT THE STERILE PACKAGING SEAL WAS NOT SEALED. 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433217 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionMar 13, 2024Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PATIENT WAS EXAMINED USING AN EXTRACTOR BALLOON. ALTHOUGH THE WIRE WAS ALREADY IN THE BILE DUCT, THE EXTRACTOR BALLOON COULD NOT BE INSERTED OVER THE WIRE. AN ATTEMPT WAS MADE TO PULL THE WIRE BACK A LITTLE, BUT UNFORTUNATELY, IT PROVED TO BE A BIT DIFFICULT. AFTER REMOVING THE EXTRACTOR BALLOON, IT WAS DISCOVERED THAT THE DISTAL TIP OF THE BALLOON WAS BENT. 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 18899549 ↗MalfunctionMar 13, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE EXTRACTOR BALLOON WAS PUSHED INTO THE BILE DUCT, A KINK OCCURRED IN FRONT OF THE PAPILLA. THE EXAMINER THEN WANTED TO INSERT A JAGWIRE 0.035 TO PROVIDE SOME STIFFENING, BUT THIS WAS NOT POSSIBLE TO ADVANCE BECAUSE THE DISTAL TIP OF THE BALLOON WAS BENT. 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 18899408 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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