IMAGER™ II M001314580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729736608), received between Nov 25, 2019 and Dec 19, 2025 — classified as 1 injury, 3 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 16, 2026.

Recalls naming this device

1. Aug 24, 2026Open, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 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 ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE A DETACHED TIP. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN EMBOLIZATION OF THE RENAL ARTERY. THE CONDITION OF THE VESSEL WAS A STRAIGHTFORWARD RENAL ARTERY. WHILE INSERTING THE CATHETER INTO THE PATIENT, THE DISTAL TIP DETACHED. THERE WAS NO RESISTANCE NOTED DURING USE OF THE DEVICE. THE TIP MIGRATED TOWARD THE AORTA. AN INITIAL ATTEMPT AT RETRIEVAL WAS UNSUCCESSFUL BECAUSE THE TIP HAD BECOME ADHERED TO THE AORTIC WALL. A NEW VASCULAR ACCESS SITE WAS CREATED, AND A NEW SHEATH WAS USED FROM THE NEW SITE. WHEN THE DETACHED TIP EVENTUALLY MOVED, IT WAS REMOVED FROM THE LOWER PART OF THE LEG VIA SNARE. WHEN THE TIP WAS EXTRACTED FROM THE SHEATH, IT HAD BROKEN INTO SMALL FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853499 ↗
• MalfunctionSep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F CONTRA IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER. THERE WAS NO REPORTED COMPLAINT AGAINST THIS RETURNED DEVICE. THE DEVICE WAS INTACT UPON RECEIPT. BOSTON SCIENTIFIC CARRIED OUT FUNCTIONAL TESTING ON THE RETURNED DEVICE WHICH RESULTED IN A TIP DETACHMENT. THIS EVENT IS ASSOCIATED WITH PREVIOUSLY REPORTED FIELD ACTION 92484513-FA WITH PRODUCT BEING REMOVED FROM THE FIELD.

  Patient problems: No Patient Involvement

  MAUDE report 10475944 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNUSED 5F CONTRA IMAGER II ANGIOGRAPHIC CATHETER IN IT'S UNOPENED ORIGINAL PACKAGING WAS RETURNED TO BOSTON SCIENTIFIC FROM A CUSTOMER. THERE WAS NO REPORTED COMPLAINT AGAINST THIS RETURNED DEVICE. THE DEVICE WAS INTACT UPON RECEIPT. BOSTON SCIENTIFIC CARRIED OUT FUNCTIONAL TESTING ON THE RETURNED DEVICE WHICH RESULTED IN A TIP DETACHMENT. THIS EVENT IS ASSOCIATED WITH PREVIOUSLY REPORTED FIELD ACTION (B)(4) WITH PRODUCT BEING REMOVED FROM THE FIELD.

  Patient problems: No Patient Involvement

  MAUDE report 10474505 ↗
• 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 9370615 ↗