PINNACLE RSS906Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701007748), received between Aug 20, 2019 and Aug 20, 2019 — classified as 2 injuries.
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
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2019Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED AN UNKNOWN ISSUE WITH THE VALVE ON THE IK, THE VALVE WAS EITHER LEAKY OR BAD. THE PATIENT BLED HEAVILY WHILE THE SHEATH WAS IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 8, 2019. THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE BLOOD LOSS WAS BETWEEN 300CC AND 400CC. THE SHEATH WAS REMOVED, PRESSURE WAS HELD ON THE WOUND AND ANOTHER SHEATH FROM A DIFFERENT LOT WAS USED AND THE OUTCOME WAS GOOD.
Patient problems: Blood Loss
MAUDE report 8910090 ↗InjuryAug 20, 2019Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED AN UNKNOWN ISSUE WITH THE IK SHEATH; THE VALVE WAS LEAKY OR BAD. THE PATIENT BLED WHILE THE SHEATH WAS IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 8, 2019. THE BLOOD LOSS WAS MINIMAL, IT WAS LESS THAN 250CC. THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE SHEATH WAS REMOVED, PRESSURE WAS HELD ON THE WOUND AND ANOTHER SHEATH FROM A DIFFERENT LOT WAS USED.
Patient problems: Blood Loss
MAUDE report 8910089 ↗
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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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