PINNACLE RSB503Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701009322), received between Nov 14, 2018 and Aug 9, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2019Break; Break
THE USER FACILITY REPORTED THAT WHILE PERFORMING A LEFT HEART CATHETERIZATION AND WHILE PLACING THE PINNACLE SHEATH ON THE .035 GUIDEWIRE THE DOCTOR NOTICED THAT THE TIP OF THE DILATOR BROKE OFF AND WAS SEPARATE FROM THE SHEATH. THE DOCTOR INSTANTLY REMOVED THE FROM THE GUIDEWIRE AND GOT ANOTHER SHEATH AND PLACED THE NEW PINNACLE DEVICE IN THE PATIENT'S VESSEL. THE PATIENT DID FINE AND WAS LATER DISCHARGED HOME WITH NO ADVERSE EVENTS. THE SHEATH WAS A 5FR X25CM. THE PROCEDURE WAS A SUCCESS AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED INFORMATION RECEIVED 06/AUGUST/2019: IT WAS REPORTED THAT PIECES OF THE DEVICE WAS LEFT IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8878991 ↗MalfunctionNov 14, 2018Material Deformation; Material Deformation
THE USER FACILITY REPORTED THAT IK SHEATH WAS KINKED BEFORE COMING OUT OF THE PACKAGE. THE PACKAGE LOOKED LIKE IT HAD NEVER BEEN OPENED. THE CASE WAS A PERIPHERAL LEG CASE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. A SECOND TERUMO SHEATH WAS OPENED AND USED TO COMPLETE THE CASE SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8069342 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- 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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