Guidezilla IIRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 437
- Deaths reported
- 5
- Injuries reported
- 27
- Recalls
- 1
We found 4 models of Guidezilla II by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 437 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2017 and Sep 29, 2026 — classified as 5 deaths, 27 injuries, 405 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (101 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Guidezilla II recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 24, 2019Terminated
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Z-0578-2020 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Guidezilla II problems
Device problems
- Difficult to Advance101
- Break98
- Failure to Advance80
- Adverse Event Without Identified Device or Use Problem61
- Material Deformation57
- Material Integrity Problem46
- Detachment of Device or Device Component43
- Device-Device Incompatibility34
Patient problems
- No Clinical Signs, Symptoms or Conditions314
- No Consequences Or Impact To Patient84
- Vascular Dissection12
- No Known Impact Or Consequence To Patient9
- No Patient Involvement7
- Cardiac Arrest2
- Dyspnea2
- Foreign Body In Patient2
Guidezilla II models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Guidezilla™ II H7493933515060CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Guidezilla™ II H74939335150610CATHETER, PERCUTANEOUS2 deaths104 reports
- Guidezilla™ II H7493933515070CATHETER, PERCUTANEOUS1 recall53 reports
- Guidezilla™ II H7493933515080CATHETER, PERCUTANEOUS2 reports
Recent Guidezilla II adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Remove; Device-Device Incompatibility; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938657 ↗MalfunctionSep 16, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794312 ↗MalfunctionSep 16, 2026Nonstandard Device; Failure to Advance
Reportable based on the device analysis completed on (b)(6) 2026.It was reported that the device failed to cross the lesion due to calcification.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous left anterior descending artery. A Guidezilla II, 6F was selected for use. During introduction, the device failed to cross the lesion due to calcification. The procedure was completed with another of the same device. The procedure was completed and the patient was stable with no complications.However, analysis of the returned device revealed that the collar was detached.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791825 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782151 ↗MalfunctionSep 9, 2026Difficult to Remove; Difficult to Advance; Material Integrity Problem
It was reported that withdrawal difficulty occurred.The 85% stenosed target lesion was located in the severely tortuous and moderately calcified left anterior descending artery. A 7F Guidezilla II guide extension catheter was selected for use. When the device was advanced through the proximal and curved segments of the target vessel, there was a significant increase in resistance, and it was difficult to cross the angulation. Abnormal tension was encountered during withdrawal of the catheter. Upon inspection, the catheter exhibited a collapsed and kinked distal tip. Further examination identified lumen narrowing and deformation. The procedure was completed with another of the same device. There were no patient complications, and the patient condition following the procedure was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50682286 ↗MalfunctionSep 9, 2026Difficult to Remove; Device-Device Incompatibility; Material Integrity Problem
It was reported that withdrawal difficulty occurred.The 90% stenosed target lesion of Right Coronary Artery was severely tortuous and moderately calcified. A 6F Guidezilla II was used to advance the treatment. When the device was advanced through the proximal and curved segments of the target vessel, there was a significant increase in resistance, and it was difficult to cross the angulation. Abnormal tension was encountered during withdrawal of the catheter. Upon inspection, the catheter exhibited a collapsed and kinked distal tip. Further examination identified lumen narrowing and deformation. The procedure was completed with another of the same device. There were no patient complications, and the patient condition following the procedure was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50682285 ↗MalfunctionSep 9, 2026Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance
It was reported that withdrawal difficulty and collar fracture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery. A 6F Guidezilla II guide extension catheter was selected for use. When the device was advanced through the proximal and curved segments of the target vessel, there was a significant increase in resistance, and it was difficult to cross the angulation. Abnormal tension was encountered during withdrawal of the catheter. Upon inspection, the catheter exhibited a collapsed and kinked distal reinforcement section. Further examination revealed lumen narrowing and deformation, along with a localized fracture of the metal braided wires, consistent with structural failure of the distal segment. The device was removed without any problem using normal method. The procedure was completed with another of the same device. There were no patient complications, and the patient condition following the procedure was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50682284 ↗MalfunctionSep 8, 2026Material Separation; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678107 ↗MalfunctionAug 31, 2026Break; Material Puncture/Hole
It was reported that the catheter ruptured.A 6F Guidezilla II was selected for use. At the course of the procedure, prior to performing a coronary stent implantation, a catheter rupture was detected. The procedure was completed with another of the same device. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531510 ↗MalfunctionAug 20, 2026Break; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50360069 ↗MalfunctionAug 19, 2026Nonstandard Device; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331343 ↗MalfunctionAug 14, 2026Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247512 ↗MalfunctionAug 14, 2026Difficult to Remove; Material Separation; Failure to Advance; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246811 ↗MalfunctionAug 12, 2026Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217374 ↗MalfunctionAug 6, 2026Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159151 ↗
Other Boston Scientific Corporation products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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