Boston Scientific Channel Steerable Sheath M004CS200Recalls & reported problems
Greatbatch Ltd · Channel Steerable Sheath, 9 French · Class 2
Data updated Oct 18, 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 08714729862420), received between Aug 14, 2020 and Aug 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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 18, 2026.
Most reported problems
Device problems
- Material Frayed1
- Material Protrusion/Extrusion1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2020Material Frayed; Material Protrusion/Extrusion; Material Frayed; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE STEERING FIBER WAS PULLED OUT OF THE DISTAL TIP OF THE SHEATH. THE SHEATH WAS REMOVED WITHOUT HARM TO THE PATIENT. THE REPORT WAS COMMUNICATED ON (B)(6) 2020.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10407364 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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