PINNACLE PRECISION ACCESS SYSTEM 70-4165Recalls & reported problems
Terumo Medical Corporation · PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath · Class 2
All models of PINNACLE PRECISION ACCESS SYSTEM (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701010861), received between Apr 8, 2021 and Jun 4, 2025 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE DOCTOR PLACED THE PRECISION SHEATH AND WHEN REMOVED WIRE, THE WIRE WAS SHREDDED. THERE WAS NO HARM TO PATIENT AND PROCEDURE WAS COMPLETED WITH NO ISSUES. PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC CHOLECYSTECTOMY (L/C). THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 09MAY2025: NOTHING WAS LEFT IN THE PATIENT PER THE PHYSICIAN. THE PHYSICIAN USED A DIFFERENT MICRO WIRE AND EXCHANGED THE PRECISION FOR A PINNACLE WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22144480 ↗InjuryApr 8, 2021Break; Break
THE USER FACILITY REPORTED THAT THE IK PRECISION WIRE WAS INSERTED AND THERE WERE ISSUES PULLING THE WIRE BACK THROUGH THE NEEDLE. TENSION WAS MET, PULLED THE ENTIRE NEEDLE AND THE WIRE CAME OUT TOGETHER AND PART OF THE WIRE BROKE OFF IN PATIENT. A CUTDOWN WAS PERFORMED IN THE OPERATING ROOM TO REMOVE THE WIRE. THE PATIENT WAS STABLE, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 19MARCH2021: IT WAS DECIDED NOT TO SEND THE PATIENT FOR SURGERY BECAUSE THEY THOUGHT THE WIRE WAS NOT IN THE VESSEL, BUT OUTSIDE OF THE VESSEL
Patient problems: Foreign Body In Patient
MAUDE report 11634084 ↗
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