Mach1™ M001196450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729403500), received between May 28, 2019 and Jul 23, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS FOREARM. A 6F MACH 1 CATHETER-GUIDE WAS USED IN A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) OF CHRONIC RENAL FAILURE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS UNABLE TO PASS THROUGH, AND THE DEVICE WAS UNABLE TO SUPPORT THE SYSTEM. THE PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THIS ISSUE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314497 ↗
• MalfunctionMay 28, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A MODEL-6F PV MACH1 WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS TAKEN OUT FROM THE BOX, IT WAS FOUND TO BE SEPARATED AND BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647175 ↗