IMAGER™ II M001314330Recalls & 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729736356), received between Aug 5, 2020 and Aug 5, 2020 — classified as 1 injury.
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
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 5F SIM1 IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR A UTERINE ARTERY FIBROID EMBOLIZATION PROCEDURE. THE CATHETER TIP DETACHED WHILE ADVANCING INSIDE THE PATIENT. NO RESISTANCE WAS ENCOUNTERED DURING USE AND THE ANATOMY WAS NOT TORTUOUS. THE DETACHED TIP WAS SNARED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.
Patient problems: No Code Available
MAUDE report 10369119 ↗
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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
- 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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