IMAGER™ II M001314590Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729736615), received between Nov 25, 2019 and Jan 8, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE DURING A SUPERFICIAL FEMORAL ARTERY INTERVENTION. HOWEVER, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT AND IN THE PROCESS OF SNARING, THE TIP WAS CUT INTO HALF. THE LARGEST PORTION OF THE CATHETER TIP WAS REMOVED, WHILE A SMALL PORTION BECAME EMBEDDED IN THE ILIAC ARTERIAL WALL. SUBSEQUENTLY, A STENT WAS USED TO TRAP THE EMBEDDED TIP IN THE ILIAC PORTION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9565694 ↗
• MalfunctionNov 25, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. THE CATHETER WAS PLACED OVER A NON-BSC GUIDEWIRE. AS THE CATHETER TIP WAS STRAIGHTENED IT SNAPPED AT THE APEX OF THE TIP ANGLE. ANOTHER IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FROM THE SAME LOT NUMBER. PRIOR TO USE, THE CATHETER TIP WAS STRAIGHTENED MANUALLY TO TEST IF TIP WOULD BREAK. THE TIP REMAINED INTACT, AND ANGIOGRAPHIC CATHETER WAS PLACED OVER NON-BSC GUIDEWIRE. AS THE CATHETER TIP WAS STRAIGHTENED IT SNAPPED AGAIN AT THE APEX OF THE TIP ANGLE. ANOTHER IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FROM A DIFFERENT LOT NUMBER. THE CATHETER WAS SUCCESSFULLY LOADED ONTO THE NON-BSC GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. UPON REMOVAL OF THE CATHETER, WHICH HAD A NON-BSC MICROCATHETER WITHIN THE DEVICE, IT WAS NOTICED ON FLUOROSCOPY THAT THE TIP OF THE IMAGER CATHETER HAD AGAIN SNAPPED. THE TIP WAS FREE FLOATING AROUND THE TIP OF THE NON-BSC MICROCATHETER. THE IMAGER II CATHETER AND MICROCATHETER WERE REMOVED SUCCESSFULLY FROM THE SHEATH AND PATIENT. AFTER THE PROCEDURE THE SCRUB NURSE STATED THAT THE CATHETER TIPS FELT BRITTLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370638 ↗
• MalfunctionNov 25, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. THE CATHETER WAS PLACED OVER A NON-BSC GUIDEWIRE. AS THE CATHETER TIP WAS STRAIGHTENED IT SNAPPED AT THE APEX OF THE TIP ANGLE. ANOTHER IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FROM THE SAME LOT NUMBER. PRIOR TO USE, THE CATHETER TIP WAS STRAIGHTENED MANUALLY TO TEST IF TIP WOULD BREAK. THE TIP REMAINED INTACT, AND ANGIOGRAPHIC CATHETER WAS PLACED OVER NON-BSC GUIDEWIRE. AS THE CATHETER TIP WAS STRAIGHTENED IT SNAPPED AGAIN AT THE APEX OF THE TIP ANGLE. ANOTHER IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FROM A DIFFERENT LOT NUMBER. THE CATHETER WAS SUCCESSFULLY LOADED ONTO THE NON-BSC GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. UPON REMOVAL OF THE CATHETER, WHICH HAD A NON-BSC MICROCATHETER WITHIN THE DEVICE, IT WAS NOTICED ON FLUOROSCOPY THAT THE TIP OF THE IMAGER CATHETER HAD AGAIN SNAPPED. THE TIP WAS FREE FLOATING AROUND THE TIP OF THE NON-BSC MICROCATHETER. THE IMAGER II CATHETER AND MICROCATHETER WERE REMOVED SUCCESSFULLY FROM THE SHEATH AND PATIENT. AFTER THE PROCEDURE THE SCRUB NURSE STATED THAT THE CATHETER TIPS FELT BRITTLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370608 ↗