Imager™ II M001315260Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729737209), received between May 7, 2021 and May 7, 2021 — classified as 1 malfunction.
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 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 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE TIP WAS BROKEN. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN A MESENTERIC ANGIOGRAM WITH INTERVENTION. DURING PREPARATION, THE CATHETER WAS OPENED TO THE STERILE FIELD AND WAS FLUSHED WITH HEPARINIZED SALINE. A TUG ON THE TIP WITH MINIMAL PRESSURE PULLED THE TIP OFF OF THE CATHETER BODY BEFORE INSERTION INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11793913 ↗
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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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