Guidezilla™ II H7493933515060Recalls & reported problems

Summary

The FDA's MAUDE database contains 278 adverse event reports that list this exact device (DI 08714729939450), received between Nov 17, 2017 and Sep 29, 2026 — classified as 3 deaths, 17 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Break” (62 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 278 reports, 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; 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 14, 2026Difficult to Remove; Material Separation; Failure to Advance; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246811 ↗
• MalfunctionMay 22, 2026Break; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29APR2026. IT WAS REPORTED THAT THE SHAFT BROKE DURING THE PRE-INSTALLATION OF THE CATHETER AND THE ROTATIONAL ATHERECTOMY DEVICE OUTSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING BRANCH. A 6F GUIDEZILLA WAS SELECTED FOR USE. DURING THE PRE-INSTALLATION OF THE CATHETER AND THE ROTATIONAL ATHERECTOMY DEVICE OUTSIDE THE PATIENT, THE CATHETER WAS SPLIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS AND PATIENT HAD NO ABNORMALITY AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COLLAR WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257484 ↗
• MalfunctionMay 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE COATING WAS COMPROMISED. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE Z-GLIDE COATING WAS COMPROMISED. THE DEVICE WAS NOT USED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219636 ↗
• MalfunctionMay 15, 2026Nonstandard Device; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22APR2026. IT WAS REPORTED THAT DEVICE DIFFICULTY ADVANCING OCCURRED. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING PREPARATION, THE GUIDEZILLA COULD NOT PASS THROUGH THE GUIDE CATHETER OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COLLAR AND SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186089 ↗
• MalfunctionMay 13, 2026Nonstandard Device; Deformation Due to Compressive Stress

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21APR2026. IT WAS REPORTED THAT THE DEVICE KINKED. A 6F GUIDEZILLA II WAS SELECTED FOR USE. THE GUIDEZILLA WAS FOUND KINKED AFTER UNPACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A COLLAR WELD SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160544 ↗
• MalfunctionMay 7, 2026Material Separation

  IT WAS REPORTED THAT A DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A GUIDEZILLA II WAS SELECTED FOR USE. THE GUIDEZILLA WAS LOADED ONTO THE GUIDEWIRE AND WHEN IT WAS ENTERING THE GUIDE CATHETER, IT WAS NOTED THAT THE GUIDEZILLA HAD SEPARATED AT THE COLLAR. THE DEVICE WAS REMOVED IN ONE PIECE USING THE NORMAL METHOD. THE SAME EVENT HAPPENED WITH A SECOND GUIDEZILLA. THE PROCEDURE WAS COMPLETED USING A SECOND GUIDEWIRE FOR SUPPORT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110682 ↗
• MalfunctionMay 7, 2026Material Separation

  IT WAS REPORTED THAT A DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A GUIDEZILLA II WAS SELECTED FOR USE. THE GUIDEZILLA WAS LOADED ONTO THE GUIDEWIRE AND WHEN IT WAS ENTERING THE GUIDE CATHETER, IT WAS NOTED THAT THE GUIDEZILLA HAD SEPARATED AT THE COLLAR. THE DEVICE WAS REMOVED IN ONE PIECE USING THE NORMAL METHOD. THE SAME EVENT HAPPENED WITH A SECOND GUIDEZILLA. THE PROCEDURE WAS COMPLETED USING A SECOND GUIDEWIRE FOR SUPPORT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110665 ↗
• MalfunctionApr 29, 2026Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE WAS NEARLY FRACTURED. A 6F GUIDEZILLA II WAS SELECTED FOR USE DUE TO INSUFFICIENT GUIDE CATHETER SUPPORT. ROUTINE PROCEDURES WERE PERFORMED INCLUDING DUAL-WIRE BALLOONING, PRE AND POST DILATION, STENT PLACEMENT, AND INTRAVASCULAR ULTRASOUND. NO SPECIAL MANEUVERS WERE PERFORMED. HOWEVER, SUBSEQUENT ATTEMPTS TO ADVANCE THE GUIDEWIRE FAILED. THE GUIDEWIRE WAS REPLACED BUT STILL FAILED TO PASS. THE GUIDEZILLA WAS WITHDRAWN AND IT WAS NOTED THAT THE HYPOTUBE CONNECTION WAS NEARLY FRACTURED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027313 ↗
• MalfunctionApr 15, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 23MAR2026. IT WAS REPORTED THAT NO CROSS DUE TO CALCIFICATION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS STABLE. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE SHAFT AND COLLAR DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885675 ↗
• MalfunctionApr 8, 2026Break; Failure to Advance

  IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CROSS THE DEVICE MULTIPLE TIMES, BUT THE CATHETER GOT FRACTURED. THE DEVICE WAS REMOVED IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816083 ↗
• MalfunctionApr 3, 2026Nonstandard Device; Deformation Due to Compressive Stress

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAR2026. IT WAS REPORTED THAT THE GUIDE EXTENSION CATHETER WAS KINKED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 6F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, GUIDE EXTENSION CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A COLLAR WELD PLATE SEPARATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772818 ↗
• MalfunctionApr 2, 2026Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10MAR2026. IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 6F GUIDEZILLA II CATHETER-GUIDE EXTENSION WAS SELECTED FOR AN ANGIOGRAPHY FOR TREATMENT OF DISTAL SEGMENT OF RIGHT CORONARY ARTERY. DURING UNPACKING, IT WAS FOUND THE GUIDEZILLA FRACTURED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A COLLAR WELD PLATE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767269 ↗
• MalfunctionMar 30, 2026Break; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 90% TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING BRANCH. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE HYPO AND EXTENSION SECTION COULD NOT CROSS THE STENT, AND THE SHORT TRANSITION SECTION OF HYPOTUBE AND THE VISIBLE SPIRAL SLEEVE RING CONNECTION PART FRACTURED. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDE CATHETER. 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 24734761 ↗
• MalfunctionMar 23, 2026Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CONNECTING PIPE SEGMENT BECAME LOOSE. A 6F GUIDEZILLA II WAS SELECTED FOR USE AT THE ANTERIOR DESCENDING BRANCH, ANTERIOR SEGMENT. AT THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE CONNECTING PIPE SEGMENT BECAME LOOSE, THE DEVICE BECAME STUCK WITH THE GUIDEWIRE. 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 24662371 ↗
• MalfunctionFeb 26, 2026Material Separation

  IT WAS REPORTED THAT A COLLAR DETACHMENT OCCURRED. THE 96% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 6F GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE WHILE THE DEVICE WAS INSIDE THE PATIENT, IT WAS NOTED THAT THE CONNECTION PORT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT DEVICE WAS REMOVED FROM THE PATIENT NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458937 ↗
• MalfunctionFeb 18, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 29JAN2026. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTES THAT THE DEVICE WAS UNABLE TO CROSS DUE TO CALCIFICATION. THE DEVICE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT CONDITION WAS STABLE. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE COLLAR AND SHAFT DETACHMENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379301 ↗