PINNACLE RSS804Recalls & reported problems
Terumo Medical Corporation · PINNACLE Introducer Sheath · Class 2
All models of PINNACLE (35)
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 00389701007663), received between Jan 16, 2018 and Jan 16, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
Patient problems
- Blood Loss2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2018Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT DURING A THORACIC ENDOGRAFT PROCEDURE, THE PHYSICIAN SAID THAT THE VALVE WAS LEAKING ABNORMALLY FROM THE VALVE. THE REPORTED BLOOD LOSS WAS LESS THAN 250 CC. IT WAS REPORTED THAT THE PATIENT IS FINE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS COMPLETED.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7194867 ↗MalfunctionJan 16, 2018Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED DURING AN EVAR PROCEDURE THE PHYSICIAN NOTED THAT THE VALVE OF THE SHEATH WAS LEAKING ABNORMALLY. BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS REPORTED TO BE FINE. THE PROCEDURE WAS COMPLETED.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7192906 ↗
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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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