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IMAGER™ II M001314660Recalls & reported problems

Boston Scientific Corporation · Angiographic Catheter · Class 2

All models of IMAGER II (47)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729736684), received between Dec 10, 2019 and Feb 3, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

Device problems

  • Detachment of Device or Device Component1
  • Material Integrity Problem1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE TIP DETACHED. AN IMAGER II DIAGNOSTIC CATHETER WAS SELECTED FOR USE IN THE LOWER EXTREMITY ARTERY. DURING PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BROKEN. THE PHYSICIAN FAILED TO SNARE THE TIP OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS STABLE AND THERE ARE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 9659468 ↗
  • MalfunctionDec 10, 2019Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT A SHAFT TEAR OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE DURING A VASCULAR EMBOLIZATION PROCEDURE. AN INTERLOCK 35 COIL WAS ADVANCED THROUGH THE CATHETER AND COULD NOT BE PUSHED PAST THE MIDDLE PART OF THE CATHETER. THE DEVICES WERE REMOVED AND IT WAS OBSERVED THAT THE IMAGER II ANGIOGRAPHIC CATHETER WAS TORN PREVENTING THE ADVANCEMENT OF THE COIL THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9447117 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

Sources and updates

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