PINNACLE RSS101Recalls & 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
- 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 00389701007304), received between Aug 3, 2018 and Aug 3, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Collapse” (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
- Collapse1
Patient problems
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2018Collapse; Collapse
THE USER FACILITY REPORTED WHEN INSERTING THE IK WIRE INTO THE SHEATH, THE VALVE COLLAPSED. THE SHEATH WAS REMOVED OVER THE WIRE AND AN IMPELLA WAS INSERTED. THE BLOOD LOSS WAS GREATER THAN 250CC'S. THE PROCEDURE OUTCOME WAS SUCCESSFUL, AND THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 23, 2018. THE PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7747271 ↗
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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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