RX Locking Device M00545470Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729746706), received between Mar 30, 2022 and Apr 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Detachment 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) 2026, FOR THE TREATMENT OF STONES IN THE COMMON BILE DUCT. DURING THE PROCEDURE, THE SPONGE FROM THE CLEAR BIOPSY CAP WAS PUSHED THROUGH THE CAP AND INTO THE ENDOSCOPE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SPONGE USING BIOPSY FORCEPS; HOWEVER, THE SPONGE BEGAN TO FRAGMENT DURING REMOVAL. THE ENDOSCOPE WAS THEN TAKEN TO THE REPROCESSING ROOM, WHERE THEY ATTEMPTED TO USE FORCEPS TO PUSH THE REMAINING SPONGE MATERIAL THROUGH THE WORKING CHANNEL FOR REMOVAL. THEY SUCCESSFULLY FLUSHED OUT THE REMAINING FRAGMENTS USING IRRIGATION. THE PROCEDURE WAS COMPLETED USING A SECOND RX LOCKING/BIOPSY CAP OF THE SAME DEVICE TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837704 ↗
• MalfunctionMar 9, 2026Detachment 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) 2026, TO TREAT CHOLANGITIS. DURING THE PROCEDURE, A SPHINCTERTOME DEVICE WAS ADVANCED THROUGH THE WORKING CHANNEL, AT WHICH POINT THE SPONGE BECAME DISLODGED AND LODGED WITHIN THE CHANNEL. THIS OBSTRUCTION PREVENTED ADDITIONAL DEVICES FROM BEING PASSED THROUGH THE WORKING CHANNEL. THE SPONGE WAS SUBSEQUENTLY RETRIEVED USING A BRUSH. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT SCOPE AND A NEW RX LOCKING DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544736 ↗
• MalfunctionNov 22, 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 (B)(6) 2024. PRIOR TO THE ERCP A SNARE WAS PASSED DOWN THE CHANNEL AND THE BLUNT TIP DISLODGED THE INTERNAL SPONGE OF THE BIOPSY CAP. THE PROCEDURE WAS COMPLETED WITH A NEW SCOPE AND ANOTHER 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 20759637 ↗
• MalfunctionNov 21, 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 FOR THE TREATMENT OF BILIARY STRICTURE ON (B)(6) 2024. DURING THE BEGINNING OF AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE DOCTOR PASSED THE SCOPE INTO THE DUODENUM. TWO PLASTIC STENTS WERE NOTED: ONE IN THE BILE DUCT AND ONE IN THE PANCREAS AND THE DOCTOR ATTEMPTED TO USE A SNARE TO RETRIEVE THE STENTS, BUT THE SNARE COULD NOT ADVANCE, INDICATING A BLOCKAGE IN THE SCOPE'S CHANNEL. THE SCOPE WAS REMOVED, AND A HEDGEHOG BRUSH WAS PASSED DOWN THE CHANNEL TO INVESTIGATE THE BLOCKAGE. REPORTEDLY, SOME DEBRIS CAME OUT AND IT APPEARED TO BE DIRTY, IT WAS FOUND THAT THE SPONGE FROM THE LOCKING DEVICE WAS DISLODGED AND GOT STUCK IN THE CHANNEL. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748116 ↗
• MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SPONGE WAS DISLODGED OUT OF THE LOCKING DEVICE AND GOT STOCK IN THE SCOPE. REPORTEDLY, THE SPONGE WAS RETRIEVED USING A HEDGEHOG BRUSH. IT IS UNKNOWN IF A WATER-SOLUBLE LUBRICANT WAS APPLIED TO THE TOP OF THE BIOPSY CAP PRIOR TO USE. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746633 ↗
• MalfunctionDec 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE WHEN PASSING A PIECE OF EQUIPMENT THROUGH THE BIOPSY PORT THE SPONGE DISLODGED AND WAS LODGED IN THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A NEW SCOPE AND ANOTHER RX LOCKING AND BIOPSY CAP RX LOCKING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941122 ↗
• MalfunctionMar 30, 2022Detachment 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPONGE GOT DETACHED AND WAS PUSHED DOWN INTO THE SCOPE. IT IS UNKNOWN IF A WATER SOLUBLE LUBRICANT WAS APPLIED TO THE TOP OF THE BIOPSY CAP PRIOR TO USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME 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 13950512 ↗