PINNACLE RSS604Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701007649), received between Jan 18, 2019 and May 26, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2020Material Twisted/Bent; Material Twisted/Bent
THE USER FACILITY REPORTED THAT THE DURING ROOM PREP FOR A FEMORAL ANGIOGRAM AND PRIOR TO THE PATIENT BEING BROUGHT INTO THE ROOM, DURING OPENING OF THE IK DEVICE PACKAGE IT WAS NOTED THAT THE FEMORAL SHEATH WAS BENT. A NEW SHEATH WAS OPENED AND PREPPED, AND THE PROCEDURE WENT AHEAD WITHOUT ISSUE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.
Patient problems: No Patient Involvement
MAUDE report 10088652 ↗MalfunctionJan 18, 2019Material Deformation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED JANUARY 31, 2019: THE PROCEDURE THAT WAS PERFORMED WAS A NEURO COILING. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8260710 ↗MalfunctionJan 18, 2019Material Deformation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED JANUARY 31, 2019: THE PROCEDURE THAT WAS PERFORMED WAS A NEURO COILING. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8260705 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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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