Skip to content

Mach1™ H749343566640Recalls & reported problems

Boston Scientific Corporation · Guide Catheter · Class 2

All models of Mach1 (28)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729351887), received between Aug 26, 2019 and Aug 26, 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

Device problems

  • Detachment of Device or Device Component1
  • Physical Resistance/Sticking1

Patient problems

  • Hematoma1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 26, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

    IT WAS REPORTED THERE WAS DIFFICULTY REMOVING THE CATHETER AND A PATIENT HEMATOMA OCCURRED. A 6F MACH1 GUIDE CATHETER WAS SELECTED FOR AN ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, THE PROXIMAL END OF THE CATHETER, EXTERNAL TO THE PATIENT, POPPED OFF. IT BECAME VERY DIFFICULT TO REMOVE FROM THE PATIENT. HOWEVER, THE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT. THE PATIENT SUSTAINED A MINOR GROIN HEMATOMA.

    Patient problems: Hematoma

    MAUDE report 8929936 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page