Mach1™ H749343582790Recalls & 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 08714729382331), received between Jun 29, 2023 and Jun 29, 2023 — 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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A MACH1 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, DUE TO THE ENTRANCE LESION, THE TIP OF THE GUIDE CATHETER WAS FLOATING. A ROTA BURR WAS INSERTED AND WITHDRAWN TO ABLATE THE LESION. FOLLOWING THE INSERTION AND WITHDRAWAL, THE TIP OF THE GUIDE CATHETER WAS SHAVED OFF AND THE BURR BECAME STUCK. THE SAME CATHETER WAS TAKEN OUT AND THE ROTA PROCEDURE WAS CONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17228256 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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