PINNACLE RSB603Recalls & 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
- 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 00389701007595), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (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
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Separation Problem; Separation Problem
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHILE CLOSING THE ACCESS SITE THE TUBING FROM THE SHEATH DETACHED UNEXPECTEDLY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE LEFT HEART CATHETERIZATION WAS COMPLETED SUCCESSFULLY. THE SHEATH WAS IN PLACE AND THE STAFF NOTICED THAT THE TUBING RANDOMLY DISCONNECTED WITHOUT ANY APPLICATION OF FORCE NOTED. THEY WERE ABLE TO EXCHANGE FOR AN ANGIO-SEAL 6FR SHEATH AND CLOSE THE ARTERIOTOMY WITH MINIMAL BLOOD LOSS AND NO PATIENT HARM. THERE WERE NO ADDITIONAL SUPPLIES NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605640 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
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- 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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