DESTINATION RSR07Recalls & reported problems
Terumo Medical Corporation · DESTINATION Renal Guiding Sheath · Class 2
All models of DESTINATION (21)
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 00389701006222), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionApr 18, 2024Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE TOUHY PART OF THE SHEATH BROKE OFF WHEN THEY REMOVED THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PROCEDURE PERFORMED WAS PERIPHERAL. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133251 ↗
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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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