IMAGER™ II M001315130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729737070), received between Sep 1, 2020 and Sep 1, 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.

• InjurySep 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED INSIDE THE PATIENT. A 5F PIGTAIL IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR AN INFERIOR VENA CAVA (IVC) FILTER PROCEDURE. DURING THE PROCEDURE, THE CATHETER TIP FRACTURED INSIDE THE PATIENT. UNDER FLUOROSCOPY, FIVE FRAGMENTS WERE SEEN IN THE BACK OF THE PATIENT'S LUNGS. ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENTS WITH THE USE OF A SNARE; HOWEVER, NOT ALL FRAGMENTS WERE ABLE TO BE RETRIEVED. THE PATIENT WAS ASYMPTOMATIC DURING THE PROCEDURE AND WAS STABLE POST-PROCEDURE. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10476508 ↗