IMAGER™ II M001314320Recalls & 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729736349), received between Dec 14, 2020 and Dec 14, 2020 — classified as 1 injury.
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
- 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
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 5FR IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR A SPLENIC ARTERY EMBOLIZATION PROCEDURE. A FEMORAL APPROACH WAS USED TO ACCESS THE MILDLY CALCIFIED ECCENTRICALLY SHAPED LESION. THE ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE TIP OF THE CATHETER DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE IMAGER WAS BEING INTRODUCED THROUGH A 6F SHEATH AT THE TIME OF THE TIP DETACHMENT. APPROXIMATELY 3-5CM OF THE TIP DETACHED. THE TIP WAS RETRIEVED WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11003786 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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