Rapid Exchange M00545820Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729301905), received between Jan 6, 2017 and Sep 17, 2025 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 17, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF NINE BOSTON SCIENTIFIC DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) METAL STENT PLACEMENT PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO ADVANCE THE JAGWIRE IN A JAGTOME RX. A SECOND JAGTOME RX WAS USED IN ORDER TO ADVANCE THE JAGWIRE THROUGH THE TOME WITHOUT SUCCESS. AN AUTOTOME RX WAS USED IN COMBINATION WITH A DREAMWIRE BUT ALSO THIS GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE TOME. A SECOND AUTOTOME RX WAS USED IN COMBINATION WITH A DREAMWIRE BUT ALSO THIS GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE TOME. AS A LAST ATTEMPT AN RX CANNULA WAS USED IN COMBINATION WITH A DREAMWIRE BUT WITHOUT RESULT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE PATIENT WILL BE RESCHEDULED FOR A NEXT ERCP. IT WAS REPORTED THAT THE RESCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TREATED SUCCESSFULLY, THE RESCHEDULED DATE WAS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074357 ↗
• MalfunctionFeb 16, 2023Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE RAPID EXCHANGE, THREE TANDEM XL, AND TWO CONTOUR ERCP CANNULA USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS USED IN THE "SMALL BOWEL" DURING A DUODENAL STENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE RAPID EXCHANGE OVER THE GUIDEWIRE. SIMILAR PROBLEM HAPPENED WHEN ANOTHER THREE TANDEM XL AND TWO CONTOUR ERCP CANNULA WERE USED. IT WAS REPORTED THAT THE DEVICES WERE "SEEMED TO BE INCOMPATIBLE." THE PATIENT WAS RESCHEDULED FOR ANOTHER PROCEDURE TO HAVE THE STENT PLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390799 ↗
• MalfunctionJan 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS INTENDED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION OUTSIDE THE PATIENT, AS THE PACKAGE WAS ATTEMPTED TO BE OPENED, "A BLACK GARBAGE-LIKE SUBSTANCE" WAS NOTICED INSIDE THE PACKAGING; HENCE, THE PACKAGE WAS NOT OPENED. IT WAS REPORTED THAT THERE WAS NO DAMAGE ON THE DEVICE POUCH OR SEAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: IT WAS REPORTED THAT A "FOREIGN SUBSTANCE" IN THE ACTUAL PRODUCT WAS NOTICED; HOWEVER, IT WAS NOT CHECKED IF IT WAS LOCATED IN THE DEVICE PACKAGING OR IF IT WAS IN THE OUTER POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16198607 ↗
• MalfunctionApr 4, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS INTENDED TO BE USED IN THE GASTRO BILIARY TRACT IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS FOUND THAT THE PACKAGE OF THE DEVICE WAS OPENED AND NOT SEALED. THE COMPLETE WELD SEAM AT THE BOTTOM EDGE OF THE PACKAGE WAS MISSING, COMPROMISING THE STERILE BARRIER. 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 13995055 ↗
• MalfunctionDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RAPID EXCHANGE CANNULA DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE PANCREATIC DUCT (CHANNEL OF WIRSUNG) ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE RADIOPAQUE (RO) MARKER WAS DETACHED INSIDE THE PATIENT. THERE IS NO INFORMATION IF AN ATTEMPT WAS MADE TO RETRIEVE THE DETACHED RO MARKER. THE PROCEDURE WAS COMPLETED WITH A SECOND TANDEM RAPID EXCHANGE CANNULA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11020220 ↗
• InjuryAug 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS USED DURING A COMMON BILE DUCT STONE REMOVAL PROCEDURE PERFORMED IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, THE RADIOPAQUE (RO) MARKER WAS DETACHED INSIDE THE PATIENT'S BODY. REPORTEDLY, THE DETACHED RO MARKER WAS RETRIEVED USING A BASKET CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425021 ↗
• InjuryAug 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS USED DURING A STONE REMOVAL PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, THE RADIOPAQUE (RO) MARKER WAS DETACHED AND REMAINED ATTACHED TO THE GUIDEWIRE; AND WITHOUT NOTICING IT, ANOTHER CATHETER WAS USED AND ADVANCE TO THE BILE DUCT, AND THE RO MARKER WAS DETACHED INSIDE THE BILE DUCT. REPORTEDLY, THE PHYSICIAN NOTICED THAT THE RO MARKER WAS INSIDE THE BILE DUCT, AN EXTRACTOR DEVICE WAS USED TO RETRIEVED THE RO MARKER, THEN IT WAS EXCRETED IN THE DUODENUM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423854 ↗
• MalfunctionFeb 11, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS UNPACKED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE THE PATIENT, PACKAGE OF RAPID EXCHANGE WAS OPENED AND WHEN DEVICE WAS TAKEN OUT FROM THE SHEATH, THERE WAS DIRT-LIKE FOREIGN OBJECT FOUND ON THE TIP PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A SECOND TANDEM RX CANNULA. THERE WERE 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 9693752 ↗
• MalfunctionJul 3, 2019Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RX CANNULA TAPERED TIP WAS USED IN THE BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RADIOPAQUE (RO) MARKER BAND DETACHED INTO THE BILE DUCT WHEN THE DEVICE WAS PULLED. THE TIP OF THE DEVICE WAS ALSO TORN WHEN THE DEVICE WAS REMOVED FROM THE SCOPE. IN THE PHYSICIAN'S ASSESSMENT, THE RO MARKER WILL PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A SECOND TANDEM RX CANNULA TAPERED TIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8758249 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RX CANNULA WAS USED IN THE BILE DUCT DURING A CHOLANGIOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE CLOSURE, THE X-RAY IMAGE SHOWED THE CATHETER ALONG WITH THE DETACHED RADIOPAQUE (RO) MARKER OF THE TANDEM. THERE IS NO INFORMATION IF THE DETACHED RO MARKER WAS RETRIEVED OR NOT. THE PROCEDURE WAS COMPLETED WITH A SECOND TANDEM RX CANNULA. 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 Consequences Or Impact To Patient

  MAUDE report 7634429 ↗
• InjurySep 21, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN TANDEM RX CANNULA WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN EXAMINATION OF THE PANCREATIC DUCT WAS PERFORMED USING THIS DEVICE. AFTER THIS DEVICE WAS REMOVED, A DOT IN THE PANCREATIC DUCT WAS NOTICED ON THE X-RAY IMAGE. IN THE PHYSICIAN¿S ASSESSMENT, IT WAS REPORTED THAT IT WAS THE RADIOPAQUE (RO) MARKER OF THE TANDEM THAT HAD DETACHED DURING THE EXAMINATION OF THE PANCREATIC DUCT. THE RO MARKER WAS SUCCESSFULLY RETRIEVED. 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 Consequences Or Impact To Patient

  MAUDE report 6885283 ↗
• MalfunctionAug 30, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RX CANNULA WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE C-CHANNEL GOT TORN TO THE TIP OF THE DEVICE. THE RO MARKER DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TANDEM RX CANNULA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6829501 ↗
• MalfunctionJul 26, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RX CANNULA WAS USED DURING A PROCEDURE PERFORMED ON (B)(4) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A FOREIGN OBJECT WAS FOUND STICKING TO THE GREEN GUIDE WIRE INTRODUCER PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TANDEM RX CANNULA. 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 UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6743651 ↗
• MalfunctionMay 25, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RX CANNULA WAS USED DURING A BILE DUCT SELF-EXPANDABLE METALLIC STENT (SEMS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE CANNULA TIP WAS FOUND TO BE BROKEN DURING THE PROCEDURE. REPORTEDLY, II WAS SUSPECTED THAT THE CAUSE WAS THE EXCESSIVE TENSION APPLIED WHEN PULLING OUT THE CANNULA. THE PROCEDURE WAS COMPLETED WITH ANOTHER TANDEM RX CANNULA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO PATIENT INJURY WAS REPORTED AT THE CONCLUSION OF THE PROCEDURE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; RO MARKER DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6592846 ↗
• InjuryJan 6, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RX CANNULA TAPERED TIP WAS USED IN THE BILE DUCT DURING A BILIARY CATHETERIZATION PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RADIOPAQUE (RO) MARKER OF THE CANNULA WAS DETACHED AND REMAINED INSIDE THE PATIENT'S BILE DUCT. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE DETACHED PIECE USING AN EXTRACTOR BALLOON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL INFORMATION RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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

  MAUDE report 6231165 ↗
• InjuryJan 6, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM RX CANNULA TAPERED TIP WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RADIOPAQUE (RO) MARKER OF THE CANNULA WAS DETACHED AND REMAINED INSIDE THE PATIENT'S PANCREATIC DUCT WHICH WAS VISIBLE ON THE RADIOSCOPY. ON (B)(6) 2016, THE RO MARKER WAS RETRIEVED BY PUSHING IT FROM BILIARY TRACT TOWARDS THE SMALL INTESTINES USING A DILATATION BALLOON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL INFORMATION RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6229015 ↗