Mach1™ H74934356103A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729119203), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionApr 3, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING. A MACH1 GUIDE CATHETER WAS SELECTED FOR USE. DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), WHEN THE IVUS CATHETER WAS PULLED OUTSIDE THE BODY AFTER LESION EVALUATION, IT WAS NOTED THAT IT GOT PULLED OUT WITH DEFLECTION BETWEEN THE IVUS CATHETER AND GUIDEWIRE. THE TIP OF THE GUIDE CATHETER WAS STUCK. DIFFICULTY ON PULLING THE SYSTEM OUTSIDE THE BODY WAS AVOIDED. HOWEVER, THE TIP OF THE GUIDE CATHETER BROKE. THE IVUS CATHETER WAS TRIED TO USE AGAIN, BUT THE IMAGE DID NOT DISPLAY, AND IT SEEMED THAT LOST IMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE OF THE SAME MODEL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478276 ↗