CorPath GRX Control Console 301Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816280023017), received between Nov 28, 2017 and Sep 21, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Activation Problem

  AFTER 1ST STENT PLACEMENT AN KB INFLATION (CRUX CORDS) PROXIMAL TO THE STENT IN 3RD SEG. OF RCA FLOW LIMITING DISSECTION APPEARED. THE ATTEMPT TO ROBOTICALLY DELIVER THE STENT TO COVER IT OR BALLOON TO DO ADDITIONAL LESION PREPARATION FAILED. DUE TO CLINICAL CONDITION (CHEST PAIN AND ECG CHANGES) DECISION WAS TO SWITCH TO MANUAL. AFTER SUCCESSFUL 2ND STENT IMPLANTATION AND CLINICAL STABILIZATION 3RD STENT AND FINAL BALLOONING DONE ONCE MORE ROBOTICALLY.

  Patient problems: Chest Pain

  MAUDE report 12509398 ↗
• MalfunctionAug 31, 2021Insufficient Device Problem Information

  AFTER SUCCESSFUL PCI PROCEDURE PATIENT COMPLAINED OF DIFFICULT SPEECH AND PARESTHESIA ON THE LEFT SIDE OF THE FACE AND TONGUE WITH DECREASED STRENGTH OF RIGHT ARM AND VERTIGO. IN BRAIN CT ON 5.08 THERE WERE NO FRESH FOCAL LESION, ONLY PERIVENTRICULAR LEUCOARAIOSIS. ON ANGIO-CT PROBABLY OLD LEFT COMMON CAROTID OCCLUSION WHICH WAS NOT KNOWN PREVIOUSLY. THE SITE STATES THAT THE EVENT WAS NOT DEVICE RELATED.

  Patient problems: Movement Disorder; Paresthesia; Speech Disorder; Vertigo

  MAUDE report 12392430 ↗
• MalfunctionNov 5, 2019Component or Accessory Incompatibility; Component or Accessory Incompatibility

  WHILE MANIPULATING THE GUIDE CATHETER FROM THE CONTROL CONSOLE, IT WAS OBSERVED THAT THE GUIDE CATHETER PROLAPSED AT THE SHEATH HUB. THE CASE WAS CONVERTED FROM A ROBOTIC TO A MANUAL PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281522 ↗
• MalfunctionMay 30, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE GREEN LIGHT WHICH INDICATES THAT THE CAPACITIVE TOUCH FEATURE OF THE DEVICE JOYSTICK IS ACTIVE REMAINED ON EVEN WHEN THE USER TOOK HIS HAND OFF OF THE JOYSTICK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655685 ↗
• MalfunctionJul 24, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE SYSTEM BECAME UNRESPONSIVE WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK THE SUPPORT TRACK TO MANUALLY SEAT THE GUIDE CATHETER. AS A RESULT, THE BALLOON CATHETER AND GUIDEWIRE WERE STILL ENGAGED IN THE CASSETTE AND STUCK WITHIN THE PATIENT. THE EMERGENCY RELEASE BUTTON ON THE CASSETTE WAS PRESSED AND THE CASSETTE WAS DISASSEMBLED TO REMOVE THE TRAPPED DEVICES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713735 ↗
• MalfunctionApr 5, 2018Fail-Safe Problem; Fail-Safe Problem

  WHILE USING THE CORPATH GRX SYSTEM FOR A PCI PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE GUIDEWIRE, HE NOTED THAT THE GUIDEWIRE WAS RESPONDING MORE THAN USUAL. THE JOYSTICK WAS MOVED TO THE FIRST VARIABLE SPEED LEVEL, BUT THE GUIDEWIRE WAS MOVING FASTER THAN ANTICIPATED. THE SAME ISSUE OCCURED WHEN ATTEMPTING TO ROTATE THE GUIDEWIRE. EVENTUALLY AN ALARM AND ERROR SOUNDED ON THE CONTROL CONSOLE INSTRUCTING TO "RELEASE JOYSTICK." THE CASE WAS CONVERTED TO A MANUAL PROCEDURE AND WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7400392 ↗
• MalfunctionNov 28, 2017Device Operational Issue; Device Operational Issue

  AFTER REMOVING THE PRE-DILATION BALLOON, THE STENT WAS PLACED IN THE CASSETTE AS WOULD NORMALLY BE DONE. AT THIS TIME, THE CONTROL CONSOLE SCREEN FROZE. THE USER TRIED PRESSING LOAD/EXCHANGE GUIDE, OPENING AND CLOSING THE CASSETTE COVERS AND AN E-STOP RESTART TO GET THE SCREEN TO UNFREEZE. THE PHYSICIAN HAD TO MANUALLY REMOVE THE GUIDEWIRE AND STENT FROM THE LOCKED CASSETTE AND CONVERT TO A MANUAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7065049 ↗