Single Use Biliary Stent V PBD-V621R-1007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170185199), received between Nov 7, 2023 and Mar 19, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A SMALL PLASTIC-LIKE FRAGMENT FELL OUT INTO THE PATIENT¿S BODY WHEN A NON-OLYMPUS GUIDEWIRE WAS PASSED THROUGH THE DUODENOVIDEOSCOPE. THE FRAGMENT, UNABLE TO BE CONFIRMED AS THE DISTAL END COVER OR A FRAGMENT OF THE SINGLE USE BILIARY STENT, WAS RETRIEVED WITH BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645148 ↗
• InjuryNov 7, 2023Migration; Migration

  OLYMPUS RECEIVED FURTHER INFORMATION FROM THE CUSTOMER. THE CUSTOMER CLARIFIED THAT ON 09/02/2023, THE OLYMPUS STENT WAS PLACED DUE TO OBSTRUCTION. ON 10/17/2023, IT WAS FOUND THE STENT HAD STRAYED WHEN ATTEMPTING TO REPLACE IT DUE TO CHOLANGITIS. ON 10/19/2023, ANOTHER ATTEMPT WAS MADE TO REMOVE THE STENT, BUT IT COULD NOT BE REMOVED. A NON-OLYMPUS THROUGH-AND-PASS DOUBLE PIT 7FR8CM STENT WAS THEN IMPLANTED. THE CUSTOMER REPORTED THAT FLUOROSCOPIC IMAGES WERE OBTAINED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO LOCATE THE STENT. THE STENT CURRENTLY REMAINS IN THE BILE DUCT. DATE OF ONSET AND CAUSE FOR THE PATIENT'S CHOLANGITIS WAS NOT KNOWN AND THE ONLY TREATMENT REPORTED WAS THE IMPLANT OF THE PLASTIC STENT. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Cholangitis

  MAUDE report 18086168 ↗