PINNACLE RSB803Recalls & 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 00389701007618), received between Sep 13, 2021 and Sep 13, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2021Fracture; Fracture
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5102858. THE EVENT DESCRIPTION STATES A TERUMO PINNACLE R/OII INTRODUCER SHEATH WITH RADIOPAQUE MARKER 8FR 25CM FRACTURED WAS USED DURING AN ENDOVASCULAR PROCEDURE WHICH RESULTED IN A RETAIN FOREIGN BODY. THE PATIENT REQUIRED A EXPLORATORY SURGERY AND REMOVAL OF THE RETAINED FOREIGN BODY.
Patient problems: Foreign Body In Patient
MAUDE report 12463434 ↗
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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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