Mach1™ H749343562940Recalls & reported problems
Boston Scientific Corporation · Guide Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729351306), received between Mar 5, 2020 and Mar 5, 2020 — classified as 1 death.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burning Sensation1
- Death1
- Heart Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) AND CORONARY ARTERY STENTING WITH A DRUG ELUTING STENT TREATMENT WAS SELECTED. CONTRAST MEDIA INFUSION WAS PERFORMED AND THE GUIDEWIRE WAS PLACED. BALLOON CATHETER ANGIOPLASTY WAS PERFORMED. A 6F MACH1 CATHETER WAS USED IN THE PROCEDURE. SHORTLY INTO THE PROCEDURE, THE PATIENT COMPLAINED OF BEING UNWELL AND EXPERIENCED A BURNING SENSATION IN HIS HEAD. THE PATIENT RAPIDLY DETERIORATED ON THE TABLE AND SUFFERED HEART FAILURE. PATIENT DEATH OCCURRED. IT WAS SUGGESTED BY THE TREATING CARDIOLOGIST THAT THE PATIENT EXPERIENCED A SUDDEN DETERIORATION RELATED TO POSSIBLE ANAPHYLAXIS.
Patient problems: Burning Sensation; Death; Heart Failure
MAUDE report 9793935 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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