Single Use 2-Lumen Cannula V PR-V614MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170225000), received between Jun 24, 2022 and Jun 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, PART OF THE MARKINGS ON THE SUBJECT DEVICE WERE PEELED OFF. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. THERE WAS NO DEBRIS IN THE BODY AND THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802128 ↗