PINNACLE RSB702Recalls & 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
- 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 00389701007571), received between Nov 20, 2017 and Sep 4, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Crack1
Patient problems
- No Consequences Or Impact To Patient2
- Blood Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2020Crack; Crack
THE USER FACILITY REPORTED THAT THE IK DEVICE 3WAY STOP WAS CRACKED OR DEFECTIVE. THERE WERE NO PATIENT ISSUES. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 17AUG2020: THEY RESOLVED THE ISSUE TO CONTINUE THE PROCEDURE WITH A NEW SHEATH. THE PATIENT CONDITION WAS STABLE. THE BLOOD LOSS LESS THAN 250CC.
Patient problems: Blood Loss
MAUDE report 10493558 ↗MalfunctionJun 12, 2020Break; Break
THE USER FACILITY REPORTED AFTER THE DOCTOR HAD AN ISSUE WITH THE 7FR PINNACLE. THE SECOND HUB OR ALTERNATE HUB HAD BEEN BREAKING. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO BLOOD LOSS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 19MAY2020: THE PROCEDURE WAS A PERIPHERAL ANGIOGRAM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10148937 ↗MalfunctionNov 20, 2017Break; Break
THE USER FACILITY REPORTED THAT THE DOCTOR PERFORMED LUE SCRIPTOGRAM, PLACED THE 7FR SHEATH AND BALLOON. WHEN SHEATH WAS REMOVED FROM THE PATIENT, AND NOTICED THAT THE ENTIRE SHEATH HAD BEEN SHEERED FROM HUB TO END. IT WAS REPORTED THAT THE PATIENT CONDITION WAS FINE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS COMPLETED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7046341 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page