CorPath GRX Extended Reach Arm 302Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816280023024), received between May 24, 2018 and Oct 15, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2020Break

  SERVICE PERSONNEL NOTED THAT CABLE FROM ERA(EXTENDED REACH ARM) TO ROBOTIC DRIVE DAMAGED, DURING SERVICE.

  Patient problems: Insufficient Information

  MAUDE report 10686330 ↗
• MalfunctionJul 8, 2019Unintended Movement; Unintended Movement

  THE USER NOTED THAT THE FRICTION JOINT OF THE EXTENDED REACH ARM WAS LOOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767829 ↗
• MalfunctionMay 30, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DURING A SERVICE EVENT, IT WAS DISCOVERED THAT THE POWER CABLE IN THE EXTENDED REACH ARM WAS DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655565 ↗
• MalfunctionSep 28, 2018Unintended Movement; Unintended Movement

  THE USER NOTED THAT THE FRICTION JOINT OF THE EXTENDED REACH ARM CONTINUED TO MOVE AFTER POSITIONING THE ARM. IT WAS ALSO STATED THAT THE EXTENDED REACH ARM DRIFTED WHEN PULLING BACK THE GUIDE CATHETER SUPPORT TRACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7918144 ↗
• MalfunctionMay 24, 2018Device Displays Incorrect Message; Unintended Movement; Device Displays Incorrect Message; Unintended Movement

  THE CUSTOMER REPORTED THAT DURING THE PCI PROCEDURE THE CORPATH GRX SYSTEM PROVIDED AN ERROR CODE STATING THAT THE EXTENDED REACH ARM HAD BECOME UNEXPECTEDLY UNLOCKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7540356 ↗