Mach1™ H749343562970Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729351337), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Integrity Problem1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2022Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT CARDIAC ARREST AND DISTAL TIP DAMAGED OCCURRED. A MACH1 DIAGNOSTIC GUIDE CATHETER WAS SELECTED FOR USE IN A CORONARY INTERVENTION PROCEDURE. THE DISTAL TIP WAS CRUSHED DAMAGED AND A BLOOD CLOT HAS OCCURRED, THE BLOOD FLOW WAS TEMPORARILY INTERRUPTED, RESULTING IN CARDIAC ARREST REQUIRING HOSPITAL TREATMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Cardiac Arrest
MAUDE report 15370975 ↗
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- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
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- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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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