Guidezilla™ II H7493933515080Recalls & reported problems
Boston Scientific Corporation · Guide Extension Catheter · Class 2
All models of Guidezilla II (4)
Data updated Oct 16, 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 08714729939481), received between Sep 30, 2019 and Jan 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2024Break; Break
IT WAS REPORTED THAT BREAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. AN 8F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, BREAKAGE WAS NOTED ON THE DEVICE WHEN USED AND PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18526219 ↗MalfunctionSep 30, 2019Break; Break
IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. AN 8F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE INSIDE AN 8F MACH 1 GUIDE CATHETER. THE PROCEDURE WAS 3 HOUR CHRONIC TOTAL OCCLUSION (CTO) PROCEDURE. THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING CTO ARTERY. UPON SUCCESSFUL CROSSING OF CTO AND INTERVENTION, THE GUIDEZILLA II CATHETER WAS REMOVED WITHOUT RESISTANCE. DURING WITHDRAWAL, ONLY THE HYPOTUBE WAS REMOVED. IT WAS OBSERVED THAT THE GUIDEZILLA II FRACTURED AT THE NECK WITHIN THE MACH 1 GUIDE CATHETER. THE PHYSICIAN SECURED THE FRACTURED DISTAL END OF THE GUIDEZILLA II AND REMOVED THE MACH 1 AND GUIDEZILLA II SUCCESSFULLY TOGETHER. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE USED. NO COMPLICATIONS WERE REPORTED AND PATIENT CONDITION WAS FINE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9136321 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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