Imager™ II M001315250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729737193), received between Oct 12, 2020 and Oct 12, 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.

• InjuryOct 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP DETACHED INSIDE THE PATIENT. A 4FR CONTRALATERAL IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR AN INFERIOR VENA CAVA (IVC) FILTER REMOVAL PROCEDURE. THE 4FR IMAGER WAS INSERTED VIA A JUGULAR APPROACH AND A GUIDEWIRE WAS FED THROUGH THE CATHETER AND INTO THE PREVIOUSLY IMPLANTED FILTER STRUTS TO HELP DISLODGE THE FILTER FROM THE IVC WALL. DURING THE PROCEDURE, WHEN REMOVING THE 4FR IMAGER CATHETER, THE CATHETER TIP BECAME CAUGHT ON THE STRUTS OF THE PREVIOUSLY IMPLANTED FILTER AND THE TIP OF THE 4FR IMAGER CATHETER BROKE OFF AND BECAME LODGED IN THE FILTER. AN ATTEMPT WAS MADE TO RETRIEVE THE DETACHED TIP BUT THIS WAS UNSUCCESSFUL. THERE WAS NO ATTEMPT TO REMOVE THE IMPLANTED FILTER, WITH THE DETACHED LODGED TIP, FROM THE PATIENT. THE PATIENT WAS ASYMPTOTIC WITH NO COMPLICATIONS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10662567 ↗