Mach1™ M001196480Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729403531), received between May 4, 2020 and Aug 23, 2022 — classified as 4 malfunctions.

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

• MalfunctionAug 23, 2022Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT A DISTAL TIP BREAK OCCURRED. THE 100% STENOSED, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A MACH 1 GUIDE CATHETER AND A NON-BSC DILATION CATHETER WERE SELECTED FOR USE. THE DISTAL TIP BROKE AS BOTH DEVICES WERE BEING ADVANCED TO THE LESION THAT WAS DESCRIBED TO BE HARD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279239 ↗
• MalfunctionAug 23, 2022Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT A DISTAL TIP BREAK OCCURRED. THE 100% STENOSED, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A MACH 1 GUIDE CATHETER AND A NON-BSC DILATION CATHETER WERE SELECTED FOR USE. THE DISTAL TIP BROKE AS BOTH DEVICES WERE BEING ADVANCED TO THE LESION THAT WAS DESCRIBED TO BE HARD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279207 ↗
• MalfunctionJul 20, 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

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A 6F MACH1 GUIDE CATHETER WAS SELECTED FOR USE IN A TREATMENT PROCEDURE. THE TARGET 50% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. IT WAS OBSERVED THAT THE TIP WAS DETACHED. THE DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200027 ↗
• MalfunctionMay 4, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6F MACH1 WAS ADVANCED VIA A CONTRALATERAL APPROACH OVER THE STEEP ILIAC BIFURCATION TO ASSIST IN INTRAVASCULAR ULTRASOUND (IVUS) SUPPORTED BY A NON-BSC SHEATH. HOWEVER, DURING IVUS CATHETER REMOVAL, IT FELT LIKE IT WAS STUCK AND WAS REMOVED FORCIBLY. THE MACH1 WAS THEN ATTEMPTED TO BE REMOVED BUT IT WAS STUCK INSIDE THE NON-BSC SHEATH. IT COULD NOT BE REMOVED EVEN BY PULLING FORCIBLY, AND THE MACH 1 BROKE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY TOGETHER WITH THE NON-BSC SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020502 ↗