PINNACLE RSS403Recalls & 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 00389701007311), received between May 23, 2017 and May 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
Patient problems
- 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.
MalfunctionMay 23, 2017Detachment Of Device Component; Detachment Of Device Component
THE USER FACILITY REPORTED THE TIP OF THE 4FR PINNACLE SEPARATED DURING USE WITH THE INVOLVED RSS403 DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE TIP REMAINED ON THE WIRE AND WAS RETRIEVED WITH NO INJURY TO THE PATIENT. NO OTHER INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW 4FR PINNACLE SHEATH. THE PATIENT CONDITION WAS REPORTED TO BE SATISFACTORY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6585514 ↗
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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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