Trapezoid RX M00510890Recalls & reported problems

Summary

The FDA's MAUDE database contains 482 adverse event reports that list this exact device (DI 08714729296409), received between Nov 16, 2016 and Sep 28, 2026 — classified as 53 injuries, 429 malfunctions.

The most frequently reported specific device problem is “Break” (242 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 25 most recent of 482 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915022 ↗
• MalfunctionAug 18, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304664 ↗
• MalfunctionAug 18, 2026Difficult to Advance; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50297051 ↗
• MalfunctionAug 14, 2026Difficult to Remove; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251260 ↗
• MalfunctionAug 10, 2026Break; Difficult to Open or Close

  It was reported to Boston Scientific Corporation that a Trapezoid RX was to be used in the common bile duct during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During preparation, the thumb ring detached from the handle. Another Trapezoid RX was used to complete the procedure.There were no patient complications reported, and the patient's condition following procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193693 ↗
• MalfunctionAug 10, 2026Break; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192668 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101988 ↗
• MalfunctionJul 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50078203 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057670 ↗
• MalfunctionJul 28, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050918 ↗
• MalfunctionJul 7, 2026Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE GALLBLADDER FOR STONE REMOVAL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SIDE CAR RX CHANNEL WAS DAMAGED, AND THE GUIDEWIRE COULD NOT CROSS SMOOTHLY. 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 25740372 ↗
• MalfunctionJul 7, 2026Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE GALLBLADDER FOR STONE REMOVAL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SIDE CAR RX CHANNEL WAS DAMAGED AND THE GUIDEWIRE WAS NOT EASY TO CROSS. 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 25740364 ↗
• InjuryJul 2, 2026Difficult to Remove

  It was reported to Boston Scientific Corporation that a Trapezoid RX was used in the common bile duct during an endoscopic procedure performed on (b)(6) 2026.During the procedure, the Trapezoid RX became stuck in the common bile duct after multiple attempts to remove the device. The duodenoscope was withdrawn while the device remained in the patient. The wire was cut and secured to the patient's cheek, and the patient was subsequently taken to the operating room for emergent device removal.No additional patient complications or adverse outcomes were reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 25694497 ↗
• InjuryJun 26, 2026Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TRAPEZOID RX COULD NOT EXPAND AND CONTRACT NORMALLY DURING USE. A STONE WAS INSIDE THE BASKET WHEN IT COULD NOT EXPAND NORMALLY, AND THE PHYSICIAN PULLED THE BASKET APART TO RELEASE THE STONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644136 ↗
• MalfunctionJun 19, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT FOR STONE REMOVAL DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE HANDLE WAS FRACTURED. 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 25563884 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN ATTEMPTING TO CRUSH THE STONE, THE THUMB RING BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409648 ↗
• MalfunctionJun 4, 2026Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, IT WAS REPORTED THAT THE WIRE OF THE BASKET WAS FRACTURED. BASED ON THE PHOTO PROVIDED BY THE COMPLAINANT, IT WAS OBSERVED THE SHEATH KINKED. 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 25392688 ↗
• MalfunctionJun 3, 2026Detachment of Device or Device Component; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BASKET FAILED TO CLOSE AFTER BEING OPENED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF HANDLE CANNULA DETACHED/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385147 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FRONT END OF THE BASKET WAS SEPARATED FROM THE OUTWARD WARPING AND COULD NOT BE DEPLOYED. 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 25368522 ↗
• MalfunctionMay 22, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS TO BE USED IN THE GALLBLADDER DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, IT WAS REPORTED THAT THE DEVICE FRACTURED. BASED ON THE PHOTO PROVIDED BY THE COMPLAINANT, THE WIRE INSIDE THE HANDLE IS OBSERVED TO BE BROKEN. 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 25256647 ↗
• InjuryMay 21, 2026Break; Difficult to Remove; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE BILE DUCT DURING A BILIARY TRACT STONE REMOVAL BY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BASKET WAS ADVANCED INTO THE PATIENT'S BILE DUCT TO CAPTURE A STONE. WHILE THE PHYSICIAN ATTEMPTED TO CRUSH THE STONE USING AN ALLIANCE HANDLE, THE HANDLE CANNULA OF THE TRAPEZOID RX HANDLE FRACTURED AND THE BASKET WAS UNABLE TO CRUSH STONE. THE STONE WAS STUCK IN THE BASKET, AND THE BASKET COULD NOT BE REMOVED FROM THE BILE DUCT. AFTER A SERIES OF EMERGENCY OPERATIONS, THE IMPACTED BASKET WAS FINALLY REMOVED WITH A SOHENDRA LITHOTRIPSY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING PROCEDURE IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243927 ↗
• MalfunctionMay 21, 2026Break; Use of Device Problem; Separation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED TO REMOVE A STONE (ABOUT 2.5 CM) IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THEY MANAGED TO TRAP THE STONE INSIDE THE BASKET. HOWEVER, IT WOULD NOT BREAK DURING LITHOTRIPSY EVEN WITH THE USE OF AN ALLIANCE II MULTI-PURPOSE HANDLE. THE BASKET WIRE BROKE AND SLIPPED OFF, WHILE THE BASKET TIP REMAINED INTACT AND STAYED WITHIN THE BILIARY TRACT. BASED ON THE PHOTO PROVIDED BY THE COMPLAINANT, THE TIP REMAINED IN POSITION. THE PROCEDURE WAS COMPLETED WITH USING A TRANSNASAL ENDOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. FOLLOWING THE PROCEDURE, THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243057 ↗
• MalfunctionMay 8, 2026Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT FOR LOWER ABDOMINAL PAIN DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT GUIDEWIRE SHEATH WAS RUPTURED. 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 FINDING OF SIDE CAR RX TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124210 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SIDE CAR RX OF THE DEVICE WAS TORN. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070694 ↗
• MalfunctionApr 29, 2026Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO TRAPEZOID RX DEVICES WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO CRUSH A STONE APPROXIMATELY 0.8-1.0CM STONE. THE TRAPEZOID RX SUCCESSFULLY CRUSHED THE STONE BUT THE HANDLE CANNULA BROKE. ANOTHER TRAPEZOID RX WAS USED WITH AN ALLIANCE HANDLE. THE BASKET SUCCESSFULLY CRUSHED THE STONE, BUT THE HANDLE CANNULA ALSO BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035176 ↗