Extractor Pro RX-SRecalls & 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
- 21
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 5 models of Extractor Pro RX-S by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2018 and Mar 25, 2026 — classified as 1 injury, 20 malfunctions.
The most frequently reported specific device problem is “Break” (10 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 RX-S problems
Device problems
- Break10
- Detachment of Device or Device Component4
- Deflation Problem3
- Contamination /Decontamination Problem1
- Entrapment of Device1
- Failure to Deflate1
- Material Deformation1
- Problem with Sterilization1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient10
- Foreign Body In Patient1
Extractor Pro RX-S models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Extractor™ Pro RX-S M00547300CATHETER, BILIARY, DIAGNOSTIC10 reports
- Extractor™ Pro RX-S M00547310CATHETER, BILIARY, DIAGNOSTIC6 reports
- Extractor™ Pro RX-S M00547320CATHETER, BILIARY, DIAGNOSTIC3 reports
- Extractor™ Pro RX-S M00547330CATHETER, BILIARY, DIAGNOSTIC1 report
- Extractor™ Pro RX-S M00547340CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Extractor Pro RX-S adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE BILE DUCTS DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A BALLOON CATHETER WAS DAMAGED WITHIN THE BILE DUCTS, LEAVING A FRAGMENT RETAINED IN THE ANATOMY. THE PHYSICIAN ATTEMPTED RETRIEVAL, BUT THE FRAGMENT COULD NOT BE REMOVED. A STENT WAS PLACED, PENDING FURTHER INTERVENTION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 24693995 ↗MalfunctionMar 4, 2026
FROM STAFF: PATIENT WAS SCHEDULED FOR AN ECRP WITH POSSIBLE STENT PLACEMENT. PROVIDER WAS CAUTERIZING AND DILATION TO THE AMPULLA. EXTRACTOR PRO DILATION BALLOON IN THE DUCT WAS NOT INFLATING PROPERLY. THE TUBING WAS LEAKING AT THE PROXIMAL END TO THE BALLOON. EXTRACTOR REMOVED AND REPLACED. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505687 ↗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 22708824 ↗MalfunctionJul 25, 2025Failure to Deflate; Failure to Deflate
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN USING THE BALLOON TO REMOVE A STONE, IT WOULDN'T DEFLATE. IT WAS REPORTED THAT THEY TRIED TO DEFLATE IT WITH THE SYRINGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22613004 ↗MalfunctionJul 21, 2025Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER OF THE DEVICE BROKE INTO TWO SEPARATE PIECES AS THE PHYSICIAN WAS SWEEPING THE DUCT. IT WAS REPORTED THAT NO PIECE OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. 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 22560069 ↗MalfunctionMar 4, 2024Break; Break
NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER SNAPPED WHEN THE PHYSICIAN WAS PULLING THE BALLOON OUT OF THE DUCT. THE CUSTOMER STATED THAT NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. THE SAME PROBLEM OCCURRED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18832517 ↗MalfunctionMar 4, 2024Break; Break
NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXTRACTOR PRO RX-S RETRIEVAL BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER SNAPPED WHEN THE PHYSICIAN WAS PULLING THE BALLOON OUT OF THE DUCT. THE CUSTOMER STATED THAT NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. THE SAME PROBLEM OCCURRED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18832229 ↗MalfunctionMay 31, 2023Break; Break
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 PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TIP OF THE BALLOON CATHETER BROKE JUST BELOW THE BALLOON AND WAS STUCK INSIDE THE BILE DUCT. THE PHYSICIAN SWEPT THE DETACHED TIP AND BALLOON OUT OF THE BILE DUCT USING ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032527 ↗MalfunctionAug 22, 2022Material Deformation; Material Deformation
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) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON WAS DEFORMED WHEN IT WAS INFLATED. 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 15267917 ↗MalfunctionJul 6, 2022Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CATHETER ON WHICH THE BALLOON IS MOUNTED HAS FAILED. THE BALLOON WAS ATTEMPTED TO BE TAKEN OUT; HOWEVER, IT WAS IMPOSSIBLE TO TAKE IT OUT AS IF SOMETHING WAS STUCK. THERE WAS NO ERECTOR SET UP WHEN THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14934500 ↗MalfunctionMay 25, 2021Deflation Problem; Deflation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXTRACTOR PRO RX-S RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT COMPLETELY DEFLATE EVEN WHEN THE SYRINGE WAS MOVED ALL THE WAY BACK. REPORTEDLY, THE SYRINGE WAS REMOVED AND REFILLED. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11877623 ↗MalfunctionOct 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON DEVICE WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS WITHDRAWN FROM THE PATIENT, IT WAS NOTICED THAT THE TIP OF THE CATHETER DETACHED INTO THE SCOPE. REPORTEDLY, THE SCOPE WAS THEN REMOVED FROM THE PATIENT AND THE DETACHED TIP WAS PUSHED OUT OF THE WORKING CHANNEL USING A RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10662264 ↗MalfunctionFeb 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON DEVICE WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE BALLOON BROKE OFF IN THE PANCREAS OF THE PATIENT. REPORTEDLY, THERE WAS AN ATTEMPT TO RETRIEVE THE DETACHED TIP USING ANOTHER BALLOON BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS THEN COMPLETED WITH THE SECOND EXTRACTOR PRO RX-S RETRIEVAL BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9687794 ↗MalfunctionSep 24, 2019Deflation Problem; Deflation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S 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 BALLOON COULD NOT BE DEFLATED. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE, AND THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9108748 ↗MalfunctionJun 24, 2019Deflation Problem; Deflation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S 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 BALLOON COULD NOT BE DEFLATED. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 8726896 ↗
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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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