Mach1™ H74934356260Recalls & 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 08714729351221), received between Nov 15, 2018 and Nov 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
- Adverse Event Without Identified Device or Use Problem1
- Unsealed Device Packaging1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2018Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PACKAGING SEAL WAS COMPROMISED. A MACH1 GUIDE CATHETER WAS SELECTED DURING A PATIENT PROCEDURE. THE PHYSICIAN FINISHED USING AN UNSPECIFIED DEVICE AND PLANNED TO REPLACE IT WITH THE 6F MACH1 DEVICE. HOWEVER, UPON VISUAL INSPECTION OF THE PACKAGING OF THE DEVICE, IT WAS NOTED THAT THE TAPE/SEAL WAS FOUND TO BE OPEN. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TAPE OF OUTER POUCH(BOX) WAS TORN AND LID OF OUTER POUCH(BOX) WAS OPENED. HOWEVER, THE INNER POUCH WAS NEITHER COMPROMISED NOR DAMAGED.
Patient problems: No Patient Involvement
MAUDE report 8075430 ↗
Other CATHETER, PERCUTANEOUS devices
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- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- 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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