DESTINATION 54-54503Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701008936), received between Sep 10, 2019 and Apr 14, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Difficult to Remove1
- Fracture1
Patient problems
- Foreign Body In Patient1
- Laceration(s)1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT #MW5115557. THE EVENT DESCRIPTION STATES: LEFT FEMORAL ACCESS, RIGHT LOWER EXTREMITY ANGIOGRAM AND INTERVENTION ON A PATIENT'S BYPASS GRAFT STENOSIS WAS SUCCESSFUL. HOWEVER, UPON ATTEMPTED REMOVAL OF THE SHEATH, THE SHEATH WOULD NOT COMPLETELY REMOVE AND ENDED UP FRACTURING. THIS REQUIRED THE PATIENT TO BE TRANSPORTED TO THE OPERATING ROOM FOR REMOVAL OF THE SHEATH AND A SUCCESSFUL REPAIR OF THE FEMORAL ARTERY.
Patient problems: Foreign Body In Patient; Laceration(s)
MAUDE report 16748155 ↗MalfunctionSep 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION WAS INSERTED, AND THE HUB WAS NOTICEABLY MORE LOOSE AND LEAKED MORE THAN NORMAL. A LEG ANGIO WAS PERFORMED, AND INITIAL ACCESS WAS MADE VIA MICRO ACCESS, THEN A 5FR PINNACLE WAS INSERTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED ON 03SEPT019. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE BLEEDING OCCURRED OUT OF THE SHEATH HUB; OUT OF THE DEVICE. THE BLEEDING STOPPED ONCE THE SHEATH HUB WAS SCREWED BACK ON. THE PATIENT WAS NOT OBESE. THERE WAS NO HEMATOMA NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8981168 ↗
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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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