RX Locking Device M00545210Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729746652), received between Apr 24, 2019 and Dec 20, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SPONGE OF THE BIOPSY CAP DETACHED AND BECOME LODGED IN THE SCOPE'S BIOPSY CHANNEL AS AN ACCESSORY DEVICE WAS PUSHED THROUGH. THE SCOPE WAS SENT FOR REPAIR TO REMOVE THE SPONGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858886 ↗
• MalfunctionNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING SERVICING OF THE SCOPE AFTER THE PROCEDURE, A SPONGE WAS FOUND IN THE SCOPES WORKING CHANNEL. IT IS BELIEVED THAT THE SPONGE HAD DETACHED FROM THE RX LOCKING / BIOPSY CAP. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724415 ↗
• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT PUT ANY DEVICES DOWN THE WORKING CHANNEL, THEY BELIEVED THE SPONGE OF THE LOCKING DEVICE POPPED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. REPORTEDLY, THE SPONGE WAS REMOVED WITH A BRUSH AFTER THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334848 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FOAM PIECE CAME OUT OF THE BIOPSY CAP. IT IS UNKNOWN IF A WATER SOLUBLE LUBRICANT WAS APPLIED TO THE TOP OF THE BIOPSY CAP, BEFORE USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268972 ↗
• InjurySep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FOAM OF THE LOCKING DEVICE CAME OUT OF THE SCOPE DOWN INTO THE PATIENT. THE FOAM PIECE WAS RETRIEVED. IT IS UNKNOWN IF A WATER SOLUBLE LUBRICANT WAS APPLIED TO THE TOP OF THE BIOPSY CAP, BEFORE USE. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159224 ↗
• InjurySep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FOAM OF THE LOCKING DEVICE CAME OUT OF THE SCOPE DOWN INTO THE PATIENT. THE FOAM PIECE WAS RETRIEVED. IT IS UNKNOWN IF A WATER SOLUBLE LUBRICANT WAS APPLIED TO THE TOP OF THE BIOPSY CAP, BEFORE USE. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159212 ↗
• MalfunctionNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING / BIOPSY CAP WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPONGE DETACHED WHILE THE PHYSICIAN PUSHED A DREAMTOME INSIDE THE SCOPE. IT IS UNKNOWN IF THE A WATER SOLUBLE LUBRICANT WAS APPLIED TO THE TOP OF THE BIOPSY CAP PRIOR TO USE. THE SPONGE WAS REMOVED USING A PAIR OF FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX LOCKING / BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823182 ↗
• MalfunctionFeb 15, 2021Leak/Splash; Connection Problem; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE RX LOCKING DEVICE FAILS TO LOCK ON THE WIRE. ADDITIONALLY, TENSION THAT THE RX LOCKING DEVICE PUTS ON THE WIRE LEADS TO LEAKING OF THE BIOPSY CAP. REPORTEDLY, BILE AND STOMACH FLUID LEAKS FROM THE ENDOSCOPE ONTO THE NURSES, ENDOSCOPISTS, AND THE FLOOR. REPORTEDLY, PERSONNEL ARE WEARING STANDARD PERSONAL PROTECTIVE EQUIPMENT. DUE TO THESE PROBLEMS, PROCEDURE IS PROLONGED AND IN SOME CASES PROCEDURE IS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327224 ↗
• MalfunctionJan 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN AN ATTEMPT TO INSERT THE SPCHINCTERTOME, THE SPONGE FROM THE BIOPSY CAP DETACHED AND WAS FOUND INSIDE THE SCOPE CHANNEL. IT IS UNKNOWN IF A WATER SOLUBLE LUBRICANT WAS APPLIED TO THE RX LOCKING DEVICE BIOPSY CAP PRIOR TO USE. REPORTEDLY, AN ATTEMPT TO REMOVE THE SPONGE USING A PAIR OF FORCEPS WAS NOT SUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ANOTHER SCOPE AND ANOTHER OF THE SAME RX LOCKING DEVICE BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11169642 ↗
• MalfunctionApr 3, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING DEVICE WAS USED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, AN RX LOCKING DEVICE SPONGE DETACHED FROM THE CAP. THE DETACHED SPONGE WAS NOTICED INSIDE THE CHANNEL OF THE SCOPE, AFTER THE SCOPE HAD BEEN RE-PROCESSED AND WAS BEING ATTEMPTED TO BE USED ON ANOTHER PATIENT. DURING AN ERCP PROCEDURE PERFORMED ON (B)(6) 2020, RESISTANCE PASSING A TOME WAS MET AND THAT IS WHEN THE DETACHED SPONGE FROM A PREVIOUS PROCEDURE WAS DISCOVERED INSIDE THE CHANNEL OF THE SCOPE. IT IS UNKNOWN HOW THE SPONGE WAS REMOVED FROM THE SCOPE CHANNEL. THE PROCEDURE WAS COMPLETED WITH A NEW SCOPE AND ANOTHER RX LOCKING DEVICE (REPORT 3005099803-2020-01355). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924049 ↗
• MalfunctionApr 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AN RX LOCKING DEVICE SPONGE DETACHED FROM THE CAP. THE DETACHED SPONGE WAS NOTICED INSIDE THE CHANNEL OF THE SCOPE, AFTER THE SCOPE HAD BEEN RE-PROCESSED AND WAS BEING ATTEMPTED TO BE USED ON ANOTHER PATIENT. (REPORT 3005099803-2020-01502). DURING THE ERCP PROCEDURE PERFORMED ON (B)(6) 2020, RESISTANCE PASSING A TOME WAS MET AND THAT IS WHEN THE DETACHED SPONGE FROM A PREVIOUS PROCEDURE WAS DISCOVERED INSIDE THE CHANNEL OF THE SCOPE. IT IS UNKNOWN HOW THE SPONGE WAS REMOVED FROM THE SCOPE CHANNEL. THE PROCEDURE WAS COMPLETED WITH A NEW SCOPE AND ANOTHER RX LOCKING DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924020 ↗
• MalfunctionApr 24, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE BIOPSY CAP WAS INSPECTED AT THE DISTRIBUTOR ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING OF THE OUTER BOX AT THE DISTRIBUTOR, IT WAS NOTED THAT THE DEVICE PACKAGING WAS FOUND TORN. THERE WAS NO PATIENT NOR PROCEDURE INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8544522 ↗