Imager™ II M001315010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729736950), received between Jun 14, 2021 and Jun 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• InjuryJun 14, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE CATHETER. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN A DIAGNOSTIC PROCEDURE. THE PATIENT WAS BEING TREATED FOR STENOSIS IN THE LEG. DURING THE PROCEDURE, AFTER THE SECOND OR THIRD INJECTION OF KM AT 1000PSI AND 15ML/SEC, A SHAFT HOLE WAS OBSERVED IN THE MIDDLE OF THE CATHETER. THE PROCEDURE WAS CANCELLED AS A RESULT OF THIS EVENT. SHORTLY AFTER THE PROCEDURE, THE PATIENT NOTICED A TINGLING SENSATION IN THEIR FOREARM WITH NO PULSE. EXAMINATION REVEALED THROMBOSIS IN THE FOREARM. THE THROMBOSIS WAS REMOVED MECHANICALLY, AND A PATCH WAS SUTURED. THE PATIENT WAS WELL POST PROCEDURE. THE PHYSICIAN SUSPECTS THAT THE WITHDRAWAL OF THE CATHETER MAY HAVE INJURED THE VESSEL WALL AND CAUSED THE THROMBOSIS.

  Patient problems: Diminished Pulse Pressure; Paresthesia; Thrombosis/Thrombus

  MAUDE report 11996889 ↗