IMAGER™ II M001316090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729737391), received between Jan 22, 2019 and Sep 28, 2022 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionSep 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE PERFORATION OCCURRED. THE PATIENT PRESENTED WITH AN ANEURYSM IN THE INTERNAL ILIAC ARTERY. THE IMAGER II ANGIOGRAPHIC CATHETER WAS USED FOR A COILING HYPOGASTRIC PROCEDURE. DURING THE PROCEDURE, A 0.035 INTERLOCK DIAMOND 6MM COIL WOULD NOT ATTACH. THE DEVICE WAS REMOVED 100% INTACT WITH TRADITIONAL PULL BACK. A SECOND INTERLOCK COIL OF THE SAME SIZE WAS SUCCESSFULLY INSERTED HOWEVER, UPON REMOVAL OF THE IMAGER, IT WAS NOTED THAT THE COIL HAD PERFORATED THROUGH THE THE SIDEWALL OF THE CATHETER AT THE PROXIMAL TIP BEFORE THE ANGLED SHAPE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495670 ↗
• InjuryApr 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP DETACHED. AN IMAGER II ANGIOGRAPHIC 4F CATHETER WAS SELECTED FOR USE IN A FISTULOPLASTY. WHEN THE CATHETER WAS REMOVED FROM THE BRACHIAL ARTERY, THE TIP DETACHED. THERE WAS NO RESISTANCE WHEN THE CATHETER WAS REMOVED. SURGICAL INTERVENTION WAS REQUIRED TO OPEN THE VESSEL TO REMOVE THE TIP. THE PROCEDURE HAD ALREADY BEEN COMPLETED BEFORE THE TIP DETACHED. THE PATIENT WAS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14003904 ↗
• InjuryJan 22, 2019Entrapment of Device; Material Puncture/Hole; Difficult to Remove; Entrapment of Device; Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY IN CATHETER REMOVAL AND A HOLE IN CATHETER OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS HYPOGASTRIC ARTERY. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, CATHETER WOULD NOT RELEASE FROM THE INTERLOCK 35 COIL PACK AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE. THE DEVICES WERE REMOVED BY USING A BUDDY WIRE AND AN ANOTHER DIAGNOSTIC CATHETER TO HOLD THE COIL PACK IN PLACE. NO ADDITIONAL INTERVENTION WAS REQUIRED FOR DEVICE REMOVAL. UPON FINAL REMOVAL, IT WAS NOTED THAT THERE WAS A LARGE HOLE IN THE BERN OF THE IMAGER II ANGIOGRAPHIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS CORRECTED THAT ADDITIONAL DEVICE USE OF A BUDDY WIRE AND ADDITIONAL DIAGNOSTIC CATHETER WERE REQUIRED TO HOLD THE COIL PACK IN PLACE IN ORDER TO REMOVE THE IMAGER CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267758 ↗