Roadrunner G22416Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002224162), received between Aug 9, 2016 and Nov 2, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2020Accessory Incompatible; Accessory Incompatible

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ROADRUNNER WIRE GUIDE. THE DEVICE GOT STUCK IN A CANNULA. THE PHYSICIAN USED ANOTHER CANNULA AND ANOTHER WIRE GUIDE TO COMPLETE THE PROCEDURE [LOSS OF WIRE GUIDE ACCESS]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10773227 ↗
• MalfunctionAug 9, 2016Material Frayed; Material Frayed

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ROADRUNNER WIRE GUIDE. THE DEVICE FRAYED AND UNRAVELED DURING A GASTROINTESTINAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5856967 ↗