Mach1™ H74934356190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729351153), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Break; Fluid/Blood Leak; Difficult to Remove; Material Perforation; Break; Fluid/Blood Leak; Difficult to Remove; Material Perforation

  IT WAS REPORTED THAT THE SHAFT HOLE, BREAK AND BLOOD LEAKAGE OCCURRED. A 6F MACH1 GUIDE CATHETER WAS SELECTED FOR USE. DURING ADVANCEMENT OF THE WIRE, A SMALL HOLE WAS NOTED AT THE FLUSH END OF THE CATHETER. THE WIRE WAS INADVERTENTLY PASSING THROUGH THIS HOLE, RESULTING IN BLOOD LEAKAGE. REMOVAL REQUIRED TWISTING, AND THE CATHETER END SUBSEQUENTLY SNAPPED. THERE NO PATIENT COMPLICATION REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS LESION. A HOLE WAS IDENTIFIED IN THE DISTAL PORTION OF THE CATHETER, OUTSIDE THE BODY, WHERE IT CONNECTS TO THE PRESSURE LINE. DIFFICULTY WAS ENCOUNTERED DURING DEVICE REMOVAL, AND THE DISTAL END OF THE CATHETER WAS CUT WITH SCISSORS TO ALLOW THE WIRE RETRIEVED FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE, AND THE PATIENT WAS WELL POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819316 ↗