Trapezoid RXRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 971
- Deaths reported
- 2
- Injuries reported
- 178
- Recalls
- 0
We found 4 models of Trapezoid RX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 971 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2016 and Sep 28, 2026 — classified as 2 deaths, 178 injuries, 791 malfunctions.
The most frequently reported specific device problem is “Break” (516 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 Trapezoid RX problems
Device problems
- Break516
- Material Deformation204
- Detachment of Device or Device Component130
- Adverse Event Without Identified Device or Use Problem107
- Difficult to Open or Close107
- Separation Failure106
- Material Split, Cut or Torn74
- Use of Device Problem69
Patient problems
- No Clinical Signs, Symptoms or Conditions618
- No Consequences Or Impact To Patient289
- No Code Available22
- No Known Impact Or Consequence To Patient21
- Hemorrhage/Blood Loss/Bleeding13
- Foreign Body In Patient12
- Insufficient Information3
- No Patient Involvement3
Trapezoid RX models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trapezoid RX M00510890Lithotriptor, biliary mechanical482 reports
- Trapezoid RX M00510880Lithotriptor, biliary mechanical1 death287 reports
- Trapezoid RX M00510870Lithotriptor, biliary mechanical149 reports
- Trapezoid RX M00510860Lithotriptor, biliary mechanical1 death53 reports
Recent Trapezoid RX adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 22, 2026Break; Difficult to Remove; Use of Device 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, a Trapezoid RX was used with an Alliance II Handle to attempt to crush a 10mm biliary stone. However, the handle cannula broke. The basket was manually removed from the biliary duct but with difficulty. Another Trapezoid RX was used to complete the procedure.No patient complications were reported; however, the procedure took longer than anticipated due to the equipment fault. The patient's condition following procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850698 ↗MalfunctionSep 22, 2026Break
It was reported to Boston Scientific Corporation that a Trapezoid RX was used in the biliary during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6)2026. During the procedure, the thumb ring broke during the process of crushing the biliary stone. The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850328 ↗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 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50297050 ↗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 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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