IMAGER™ II M001315200Recalls & 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 08714729737148), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Material Integrity Problem1
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.
MalfunctionNov 9, 2021Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT HUB DAMAGED OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. DURING PREPARATION, UPON OPENING THE PACKAGE THEY NOTICED THE HUB WAS SMASHED AND THEY WERE UNABLE TO USE IT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE METHOD/DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STERILE POUCH DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12778076 ↗
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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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