CorPath GRX Robotic Drive 303Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816280023031), received between Jun 19, 2018 and Sep 9, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 9, 2024Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT - "SYSTEM ERROR WHEN TRYING TO POWER UP. REPORTS OF ELECTRICAL SPARKS WHEN CONNECTING, ERROR CODE 1001."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176561 ↗
• MalfunctionJul 1, 2021Break; Material Deformation

  SERVICE REPORTS THAT DURING CONNECTION OF THE RD CABLE BY THE USER DURING SETUP, A PIN OF THE CONNECTOR WAS BROKEN. THIS RESULTED IN A BURNT CONNECTOR AND A DAMAGED PCB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12102214 ↗
• MalfunctionJul 9, 2020Thermal Decomposition of Device

  SUSPECT WIRING ISSUE AS ROBOTIC DRIVE CONNECTOR HAS A BURN MARK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10254445 ↗
• MalfunctionSep 24, 2019Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT THE ROBOTIC DRIVE DID NOT POWER ON. UPON INVESTIGATION FROM THE CORINDUS SERVICE TEAM, IT WAS NOTED THAT THE ELECTRICAL CABLE WAS BURNT AND THE PINS WERE MISSALIGNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109643 ↗
• MalfunctionApr 17, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DURING A SERVICE EVENT, IT WAS DISCOVERED THAT THE ELECTRICAL CABLES OF THE ROBOTIC DRIVE AND EXTENDED REACH ARM WERE DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522776 ↗
• MalfunctionJul 24, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE ROBOTIC DRIVE TOUCHSCREEN BECAME UNRESPONSIVE WHEN THE TECHNICIAN SELECTED "LOAD/EXCHANGE DEVICE" TO REMOVE THE GUIDEWIRE. THE SYSTEM WAS REBOOTED BUT THE "CONTINUE CASE" BUTTON COULD NOT BE SELECTED DUE TO THE UNRESPONSIVE TOUCHSCREEN. THE EMERGENCY RELEASE BUTTON ON THE CASSETTE HAD TO BE PRESSED TO DISASSEMBLE THE CASSETTE AND REMOVE THE INTERVENTIONAL DEVICES FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713953 ↗
• MalfunctionJun 19, 2018Device Issue; Device Issue

  WHEN ATTEMPTING TO CONNECT THE CABLE BETWEEN THE ROBOTIC DRIVE AND EXTENDED REACH ARM, SPARKS WERE SEEN.

  Patient problems: Electric Shock

  MAUDE report 7616354 ↗