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IMAGER™ II M001314100Recalls & 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729736127), received between May 17, 2021 and May 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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

  • Entrapment of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 17, 2021Entrapment of Device; Entrapment of Device

    IT WAS REPORTED THAT THE RENEGADE WAS STUCK AND COULD NOT BE REMOVED FROM THE IMAGER. A 135/10 RENEGADE HI-FLO AND A IMAGER II ANGIOGRAPHIC CATHETER WERE SELECTED FOR USE AS ANCILLIARY DEVICES FOR A PRECLINICAL STUDY FOR LIQUID EMBOLIC PROTOTYPES. DURING PROCEDURE, RENEGADE MICROCATHETER WAS PLACED THROUGH A IMAGER LL ANGIOGRAPHIC CATHETER. ONCE PASSED OUT THE TIP OF THE IMAGER, THE RENEGADE WAS UNABLE TO BE ADVANCED TO THE LOCATION. THE RENEGADE APPEARED TO BE LOCKED WITHIN THE IMAGER LL ANGIOGRAPHIC CATHETER AND WAS UNABLE TO BE ADVANCED TO THE TREATMENT SITE. THE RENEGADE WAS PULLED PRETTY FIRM TRYING TO GET IT BACK INTO THE IMAGER CATHETER AND IT BECAME STRETCHED. THE DEVICE WAS AGGRESSIVELY PULLED OUT IN TRYING TO SEPARATE THE TWO DEVICES AND THIS OCCURRED BOTH INSIDE AND OUTSIDE THE BODY. HOWEVER, THE RENEGADE COULD NOT BE REMOVED FROM THE IMAGER AND RENEGADE HAD TO BE CUT. THE PROCEDURE WAS COMPLETED WITH A NEW IMAGER LL AND RENEGADE CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11831284 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

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Sources and updates

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