Mach1™ H74934356720Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729352082), received between Apr 24, 2019 and Mar 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT CATHETER DETACHMENT OCCURRED. A MACH1 6F WAS SELECTED FOR USE. HOWEVER, AS THE PHYSICIAN INTRODUCED THE CATHETER, IT DETACHED. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697833 ↗
• MalfunctionMar 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. THE MACH 1 VL3.5 GUIDE CATHETER WAS SELECTED FOR USE. WHEN THE DEVICE WAS INTRODUCED, IT DETACHED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677417 ↗
• MalfunctionApr 13, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT ON THE DEVICE. A 6F VL3.5 MACH1 GUIDE CATHETER WAS SELECTED FOR USE. PRIOR TO USE, THE PHYSICIAN NOTICED AN OBJECT THAT FORMS LIKE A BLOOD ADHERED ON BOTH THE PRODUCT AND THE PACKING LIST. NO PATIENT COMPLICATIONS WERE REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953148 ↗
• MalfunctionApr 24, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE FRACTURED. TWO MACH 1 GUIDE CATHETERS WERE SELECTED FOR USE IN A CORONARY ANGIOGRAPHY PROCEDURE. DURING UNPACKING, THE DISTAL OSTIUM WAS NOTED TO BE FRACTURED. NO DAMAGE WAS NOTED DURING VISUAL OR AT PACKAGE FOR TRANSPORT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8546554 ↗