PINNACLE RSB601Recalls & reported problems
Terumo Medical Corporation · PINNACLE R/O II Introducer Sheath with Radiopaque Marker · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701007533), received between Nov 16, 2018 and Nov 16, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE USER FACILITY REPORTED THAT THE PHYSICIAN REQUESTED A IK 10CM ROII SHEATH HOWEVER A 6CM ROII SHEATH WAS OPENED AND INADVERTENTLY UTILIZED. DUE TO THE SHORTER SHEATH LENGTH THE SHEATH CAME OUT OF THE ARTERY AND A SURGICAL CUT-DOWN WAS REQUIRED TO CLOSE THE VESSEL. THE PHYSICIAN STATED THAT THE PACKAGING CONTAINS SMALL WRITING MAKING IT DIFFICULT FOR THE STAFF TO SEE WHAT PRODUCT THEY ARE OPENING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.
Patient problems: No Code Available
MAUDE report 8077255 ↗
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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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