IMAGER™ II M001314760Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729736783), received between Oct 28, 2025 and Oct 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 24, 2026Class IOpen, Classified

   Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

   Z-3214-2026 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionOct 28, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. THE CATHETER WAS FLUSHED DURING PREPARATION, HOWEVER, THE TIP DETACHED INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. IT WAS FURTHER REPORTED THAT HYDROGEN PEROXIDE WAS USED TO CLEAN THE CATHETERIZATION LAB ONCE A MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407636 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. THE CATHETER WAS FLUSHED DURING PREPARATION, HOWEVER, THE TIP DETACHED INTO TWO PIECES. THE SAME EVENT OCCURRED AGAIN WITH ANOTHER IMAGER II ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407634 ↗