DESTINATION RSC07Recalls & reported problems
Terumo Medical Corporation · DESTINATION Carotid Guiding Sheath · Class 2
All models of DESTINATION (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701007861), received between Mar 12, 2021 and Jul 14, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
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
- Material Deformation2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2021Material Deformation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED ON 19JUL2021. THE DEVICE WAS NOT USED. ANOTHER DEVICE WAS USED TO ENSURE THE OPERATION WENT SMOOTHLY. NO CLINICAL CONSEQUENCES WERE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12168275 ↗MalfunctionMar 12, 2021Material Deformation; Material Deformation
THE USER FACILITY REPORTED THERE WAS A PINCH ON THE DESTINATION INTRODUCER.
Patient problems: Insufficient Information
MAUDE report 11470514 ↗
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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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