Mach1™ H74934356220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729351177), received between Jul 31, 2019 and May 30, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 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.

• MalfunctionMay 30, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDE CATHETER BROKE. A MACH 1 GUIDE CATHETER WAS SELECTED AS PART OF TREATMENT OF THE TARGET LESION. AFTER THE GUIDE CATHETER WAS ADVANCED, IT WAS NOTICED THAT THE DISTAL END HAD COME OFF. THE DISCONNECTED PART OF THE CATHETER WAS STILL ON THE GUIDEWIRE AND WAS ABLE TO BE REMOVED WITH THE GUIDEWIRE. THE DEVICE WAS REMOVED FULLY BY PULLING IT NORMALLY OUT. ANOTHER OF THE SAME DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED, AND PATIENT CONDITION IS NORMAL POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114797 ↗
• MalfunctionJun 10, 2024Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE GOT SEPARATED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 6F MACH 1 CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, A RESISTANCE WAS FELT, AND THE CATHETER COULD NOT BE ADVANCED TO THE DESIRED POSITION. EVENTUALLY THE CATHETER GOT SEPARATED IN THE OSTIUM OF DISTAL RCA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498191 ↗
• MalfunctionJan 8, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE INNER POUCH WAS UNSEALED. A 6F MACH 1 GUIDE CATHETER WAS SELECTED FOR USE. DURING UNPACKING, THEY NOTICED THE INNER POUCH WAS UNSEALED AND THE DEVICE STERILITY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18470974 ↗
• InjuryJul 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE CATHETER DETACHED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED IN RIGHT CORONARY ARTERY (RCA). DURING THE PERCUTANEOUS CORONARY INTERVENTION (PCI), A MODEL 6F MACH 1 AL.75 WAS USED AND A NON BSC STENT WAS PLACED IN RCA PROXIMAL. WHEN THE DELIVERY BALLOON WAS PULLED AND INFLATED AT 16ATM TO DILATE THE STENT, THE BALLOON GOT PARTIALLY INFLATED INSIDE THE TIP OF THIS DEVICE. WHEN THE MODEL 6F MACH 1 AL.75 WAS PULLED TO REMOVE IT, THE TIP GOT SEPARATED FROM THE MAIN BODY. THE SEPARATED TIP WAS UNABLE TO RETRIEVE BY USING A SNARE. THE PHYSICIAN INSERTED AN UNKNOWN GUIDEWIRE AND ANOTHER UNKNOWN BALLOON CATHETER, THEN IT WAS INFLATED AND RETRIEVED THE SEPARATED TIP TOGETHER WITH THE SYSTEM. WHEN RETRIEVING REACHED TO THE BRACHIAL ARTERY, THE BALLOON RUPTURED AND THE SEPARATED TIP REMAINED INSIDE THE BODY. THE PHYSICIAN WAS HAVING DIFFICULTY IN RETRIEVING PERCUTANEOUSLY, BUT UPON FLUOROSCOPY, IT WAS FIXED IN THE STATE THAT IT ENTERED IN THE SIDE BRANCH. IT WAS REMAINED AS IT WAS AND THE PATIENT UNDERGONE FOLLOW UP OBSERVATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8848505 ↗