Mach1™ M001198380Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729481591), received between Sep 30, 2020 and Dec 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A MACH1 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DISTAL 2-3CM OF THE CATHETER WAS BROKEN AND THE DEVICE DID NOT PASS UPWARD TO THE LEFT COMMON CAROTID ARTERY. THE DEVICE WAS THEN REPLACED WITH ANOTHER GUIDE CATHETER WHICH PASSED SMOOTHLY AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS NON-CALCIFIED. THE DEVICE WAS REMOVED SAFELY, AND THE PATIENT CONDITION POST PROCEDURE WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364621 ↗
• MalfunctionSep 30, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE DEVICE ALMOST BROKE. A MACH 1 CATHETER GUIDE WAS SELECTED FOR USE. THE INTENDED LESION WAS LOCATED IN THE RIGHT CAROTID ARTERY. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY MOVING THE DEVICE INSIDE THE ARTERIES. WHEN MOVING THE DEVICE, IT ALMOST BROKE INSIDE THE PATIENT DUE TO THE WEAKNESS IN THE MIDDLE OF THE CATHETER. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10607257 ↗