DESTINATION RSR06Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701006215), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Physical Resistance/Sticking1
- Stretched1
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.
InjuryJul 18, 2025Difficult to Remove; Stretched; Physical Resistance/Sticking; Difficult to Remove; Stretched; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE SURGEON WAS PERFORMING A RIGHT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. ACCESS WAS IN THE LEFT COMMON FEMORAL ARTERY WITH A 7FR X 45CM DESTINATION SHEATH. AFTER THE PROCEDURE WAS COMPLETE, THE SURGEON ATTEMPTED TO RETRACT THE SHEATH AND ENCOUNTERED RESISTANCE. HE FELT THAT THE SHEATH WAS STRETCHING OUT AND WAS NOT COMING OUT OF THE PATIENT. THE SURGEON DECIDED TO PERFORM A CUT-DOWN OF THE COMMON FEMORAL ARTERY (CFA)TO REMOVE THE SHEATH. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE TYPE WAS A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 26JUN2025: THE PHYSICIAN STATED THAT HE DID NOT BELIEVE THERE WAS ANY ISSUE WITH THE SHEATH ITSELF, DURING THE CUT-DOWN HE FOUND THAT THE GROIN WAS VERY SCARRED AND BELIEVED IT WAS THE SCAR TISSUE THAT WAS RESISTING THE SHEATH FROM BEING REMOVED. THE PATIENT WAS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22547504 ↗
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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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