Tandem XL M00535700Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729146636), received between Jun 26, 2017 and May 8, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL WAS USED IN THE COMMON BILE DUCT AND INTRAHEPATIC BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FLUOROSCOPIC MARKER AT THE TIP WAS NOT VISIBLE UNDER FLUOROSCOPY. IT WAS REPORTED BY THE PHYSICIAN THAT THE RADIO OPAQUE (RO) MARKER MAY NOT HAVE BEEN PRESENT IN THE FIRST PLACE. 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 25124975 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, PAINT MARKER WAS NOT VISIBLE ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 21, 2023: IT WAS THE RADIOPAQUE (RO) MARKER THAT WAS NOT VISIBLE ON THE SCREEN, AND THE REASON WHY IT WAS NOT VISIBLE BECAUSE IT WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140395 ↗
• MalfunctionSep 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL WAS INTENDED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION OUTSIDE THE PATIENT, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING, A FOREIGN OBJECT WAS FOUND IN THE GUIDEWIRE LUMEN OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED A FOREIGN MATERIAL IN THE GUIDEWIRE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17724689 ↗
• 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 16390872 ↗
• MalfunctionFeb 16, 2023Difficult to Advance; Difficult to Advance

  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 16390870 ↗
• 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 16390844 ↗
• MalfunctionMar 17, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL WAS PICKED UP BY THE DISTRIBUTOR STAFF. WHEN THE DEVICE WAS PICKED UP BY THE DISTRIBUTOR STAFF FOR DELIVERY, A HAIR WAS FOUND INSIDE THE POUCH OF THE DEVICE. REPORTEDLY, THERE WAS NO DAMAGE NOTED ON THE PACKAGING OF THE DEVICE AND THE PACKAGING WAS UNOPENED AND COMPLETELY SEALED. THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11504583 ↗
• MalfunctionJun 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL WAS DELIVERED TO THE CUSTOMER. ACCORDING TO THE COMPLAINANT, DURING DELIVERY OF THE PRODUCT A HAIRLINE WAS FOUND INSIDE THE POUCH. THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10141310 ↗
• MalfunctionNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL ERCP CANNULA WAS TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE OF THE PATIENT, IT WAS OBSERVED THAT THE RADIOPAQUE MARKER BAND WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH A SECOND TANDEM XL ERCP CANNULA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356949 ↗
• MalfunctionJul 5, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM¿ XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, IT WAS NOTED THAT THERE WAS NO RADIOPAQUE (RO) MARKER ON THE TIP OF THE TANDEM.. THE PROCEDURE WAS COMPLETED WITH THIS 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663273 ↗
• MalfunctionJun 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 XL CANNULA WAS USED IN THE COLON DURING A COLON STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A FOREIGN OBJECT WAS FOUND STUCK IN THE INJECTION PORT OF THIS DEVICE. THERE WAS NO VISIBLE DAMAGE NOTED ON THE DEVICE PACKAGING. THIS DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A SECOND TANDEM XL 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 6668072 ↗