IMAGER™ II M001316670Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729737971), received between Mar 10, 2021 and Mar 16, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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 Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. TWO 4F IMAGER II ANGIOGRAPHIC CATHETERS WERE SELECTED FOR USE IN A LOWER LEG ANGIOGRAM PROCEDURE. DURING PREPARATION OUTSIDE THE BODY, THE TIPS OF THE DEVICES CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11499115 ↗MalfunctionMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN A LEFT LEG DIAGNOSTIC ANGIOGRAM PROCEDURE. DURING PREPARATION UPON REMOVAL FROM PACKAGING, THE CATHETER WAS NOTED TO BE FRACTURED 1MM PROXIMAL TO THE TIP. THE DEVICE FRAGMENT WAS DANGLING. THE DEVICE NEVER ENTERED THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS FLUSHED WITH SALINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11455724 ↗
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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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