Mach1™ H749343565740Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729350644), received between Aug 27, 2020 and Feb 4, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCT HAS A TEAR. A 6F MACH 1 CLS3.5 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PRODUCT HAS A TEAR. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305836 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. DURING A CORONARY CANNULATION PROCEDURE, A 6F MACH 1 GUIDE CATHETER BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620051 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A MACH1 GUIDE CATHETER WAS SELECTED FOR USE IN A CORONARY INTERVENTION PROCEDURE. WHEN THE DEVICE WAS APPROACHING FROM THE RADIAL THERE WAS A SPIRAL IN THE VESSEL, AND RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS REMOVED AND WHEN IT WAS BEING CHECKED OUTSIDE THE PATIENT, FORCE WAS APPLIED, AND THE SHAFT SEPARATED AT THE MIDDLE PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865508 ↗
• MalfunctionJun 13, 2023Break; Break

  IT WAS REPORTED THAT DEVICE BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A MACH1 GUIDE CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. HOWEVER, DURING UNPACKING, DEVICE WAS ALREADY BROKEN AND BUCKLED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119402 ↗
• MalfunctionJul 18, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TIP FRACTURE OCCURRED. WHILE UNPACKING A 6F MACH 1 CLS3.5 GUIDE CATHETER, A TIP FRACTURE OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047831 ↗
• MalfunctionJul 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDE CATHETER TIP DETACHED. DURING UNPACKING, IT WAS NOTICED THAT A 6F MACH1 GUIDE CATHETER TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER MACH1 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028027 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON DECEMBER 01, 2021. IT WAS REPORTED THAT THE HUB DETACHED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THIS MACH1 GUIDE CATHETER WAS SELECTED WHILE MILDLY TORQUEING THE DEVICE TO ENGAGE THE CORONARIES THE HUB DETACHED AND TWISTED OFF. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER DEVICE ANALYSIS IDENTIFIED A DETACHMENT AT THE END OF THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12963900 ↗
• MalfunctionAug 27, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY, 2.50MM MODERATELY TORTUOUS WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A MACH GUIDE CATHETER WAS SELECTED FOR USE. DURING THE CORONARY ANGIOPLASTY THE GUIDE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10459867 ↗