IMAGER™ II M001316060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729737360), received between Aug 25, 2020 and Aug 25, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER BROKE. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT COMMON ILIAC ARTERY. ACCESS TO THE LESION WAS FROM THE RIGHT GROIN. A 4FR IMAGER II ANGIOGRAHPHIC CATHETER WAS ADVANCED OVER A V-18 GUIDEWIRE. DURING THE PROCEDURE, THE IMAGER EMBEDDED IN THE CHRONIC TOTAL OCCLUSION (CTO). THE PHYSICIAN TRIED BACKING OUT THE DEVICE BUT EXPERIENCED DIFFICULTY DUE TO THE CTO. THE V-18 WIRE WAS SWITCHED TO A DIFFERENT WIRE TO SEE IF THIS WOULD HELP. THIS WAS NOT SUCCESSFUL. IN ATTEMPTS TO PULL THE IMAGER OUT FROM THE CTO, THE IMAGER CATHETER BROKE APPROXIMATELY 80MM FROM THE DISTAL END. THE BROKEN SECTION WAS RETRIEVED VIA SNARE AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT WAS FINE. IT WAS POSSIBLE THAT THE DEVICE WAS KINKED AND BROKE AT THIS LOCATION.

  Patient problems: No Code Available

  MAUDE report 10452311 ↗