Roadrunner G22419Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002224193), received between Sep 9, 2016 and Sep 9, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 9, 2016Fracture; Off-Label Use; Improper or Incorrect Procedure or Method; Fracture; Off-Label Use; Improper or Incorrect Procedure or Method

  DURING A RENDEZVOUS PROCEDURE IN THE STOMACH, THE PHYSICIAN USED A COOK ROADRUNNER WIRE GUIDE. THE WIRE GUIDE SHREDDED AFTER BEING PULLED THROUGH A COVIDIEN 22G SHARK CORE FNA/FNB NEEDLE, WHICH IS NOT INDICATED TO BE USED WITH A WIRE GUIDE IN THIS MANNER [OFF LABEL USE]. THE TIP WAS MISSING. THERE WAS NO HARM TO THE PATIENT, HOWEVER THE TIP OF THE WIRE GUIDE REMAINED IN THE PATIENT'S STOMACH. THE DEVICE WAS RECEIVED FOR EVALUATION ON 08/25/2016. TWO (2) DEVICES WERE RECEIVED WITH THE SAME MALFUNCTION (BOTH TIPS DETACHED). THE FOLLOWING CLARIFICATION ON THE SECOND DEVICE WAS RECEIVED FROM THE SALES REPRESENTATIVE: "THIS WIRE WAS USED IN THE EXACT SAME CASE WITH THE EXACT SAME RESULTS." THE FOLLOWING INFORMATION ON THE RETRIEVAL OF THE DETACHED WIRE GUIDE TIPS WAS RECEIVED 08/29/2016 VIA THE SALES REPRESENTATIVE: "THE TIPS WERE ALLOWED TO PASS NATURALLY THROUGH THE PATIENT". ON 10/12/2016, WE RECEIVED A MEDWATCH MW5065042 VIA THE FDA THAT STATED THE FOLLOWING: "PATIENT WAS UNDERGOING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). PHYSICIAN ATTEMPTED MAIN PANCREATIC CANNULATION BUT WAS UNSUCCESSFUL. HE THEN ATTEMPTED AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) GUIDED ERCP, BUT THE

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5939691 ↗