CorPath GRX Cassette 305Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816280023055), received between Nov 9, 2018 and Sep 23, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Component or Accessory Incompatibility; Component or Accessory Incompatibility

  WHILE MANIPULATING THE GUIDE CATHETER FROM THE CONTROL CONSOLE, IT WAS OBSERVED THAT THE GUIDE CATHETER POPPED OUT AND BUCKLED. THE PHYSICIAN WAS UN-ABLE TO RE-ENGAGE THE GUIDE CATHETER AND HAD TO CONVER THE CASE TO A MANUAL PROCEDURE. THE CASE WAS SUCCESSFULLY COMPLETED MANUALLY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106417 ↗
• MalfunctionJul 22, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  PER THE FACILITY, DURING ROBOTIC DELIVERY OF THE GUIDEWIRE, THE WIRE WRAPPED AROUND THE REAR OF THE ROTARY DRIVE OF THE CASSETTE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8811180 ↗
• MalfunctionNov 29, 2018Component or Accessory Incompatibility; Component or Accessory Incompatibility

  WHILE MANIPULATING THE GUIDE CATHETER FROM THE CONTROL CONSOLE, THE CATH LAB TECHNICIAN SAW THE GUIDE CATHETER PROLAPSE THRU THE GUIDE SUPPORT TRACK AT THE SHEATH. THE CATH LAB TECHNICIAN PRESSED THE EXCHANGE GUIDE BUTTON AND RESUPPORTED THE GUIDE CATHETER. AFTER THIS, THE CASE WAS FINISHED WITH THE SAME GUIDE CATHETER WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8115452 ↗
• MalfunctionNov 9, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT HAD A HIGHLY CALCIFIED LESION AND POOR GUIDE SUPPORT. WHEN ATTEMPTING TO MOVE THE GUIDE CATHETER FORWARD USING THE CORPATH GRX SYSTEM, THE GUIDE CATHETER KINKED, WHICH ALSO PROMPTED A SYSTEM ERROR. THE CASE WAS CONVERTED FROM A ROBOTIC PROCEDURE TO A MANUAL PROCEDURE, HOWEVER IT WAS STILL UNABLE TO BE COMPLETED DUE TO THE CALCIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8055503 ↗