Chaperon Guiding Catheter GC695M2VTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170013157), received between Jun 19, 2019 and Sep 8, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Patient Device Interaction Problem; Physical Resistance/Sticking; Patient Device Interaction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT IN THE INTRACRANIAL STENOSIS SURGERY EMPLOYING A GUIDE CATHETER ENCOUNTERED A COMPLICATION. THE INTERMEDIATE / MIDDLE CATHETER FAILED TO PASS THROUGH THE DISTAL END / TIP OF THE GUIDING CATHETER DURING THE PROCEDURE, RESULTING IN THE INABILITY TO COMPLETE THE PROCEDURE. ANOTHER BRAND'S LONG SHEATH WAS USED AS A REPLACEMENT, BUT THE INTERMEDIATE / MIDDLE CATHETER STILL COULD NOT PASS THROUGH DURING DELIVERY. THE PATIENT WAS REPORTED TO BE FINE; POSTOPERATIVE RECOVERY IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992921 ↗
• MalfunctionJun 19, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE INNER PACKING BAG CONTAINING THE STERILE DEVICE WAS UNSEALED FOR A LENGTH OF APPROXIMATELY 5 CM. THE DEVICE ISSUE WAS DISCOVERED IN THE WAREHOUSE PRIOR TO DISTRIBUTION TO A CUSTOMER FACILITY.

  Patient problems: No Patient Involvement

  MAUDE report 8714695 ↗