PINNACLE RSB703Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701007601), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 injury.
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
- Foreign Body Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2025Separation Problem; Separation Problem
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT WAS SCHEDULED TO HAVE AN ABLATION PROCEDURE, A 7FR TERUMO SHEATH WAS INSERTED IN RIGHT FEMORAL VEIN HOWEVER ON REMOVAL FOR A STANDARD EXCHANGE OF THE SHEATH IT FRACTURED IN THE PATIENT. THE LARGE PORTION OF SHEATH THAT WAS FRACTURED IN THE PATIENT WAS LATER REMOVED THAT DAY BY THE DOCTOR FROM VASCULAR SURGERY, THE SHEATH WAS PLACED IN A STERILE CUP. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 12NOV2025: THERE WAS TORTUOSITY EXPERIENCED WHEN THE SHEATH BREAK OCCURRED DURING REMOVAL. THE PATIENT WAS NOT IN SPASM WHEN THE BREAK OCCURRED. THERE WAS SOME RESISTANCE EXPERIENCED DURING SHEATH REMOVAL FROM THE PATIENT. THE INTENDED ABLATION PROCEDURE WAS ABLE TO BE COMPLETED FOR THE PATIENT ON (B)(6) 2025. THE PATIENT CONDITION WAS STABLE, HOWEVER TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND THEN TO THE OPERATING ROOM (OR) TO VASCULAR SURGERY FOR A CUT DOWN PROCEDURE TO RETRIEVE RETAINED PORTION OF THE SHEATH.
Patient problems: Foreign Body Embolism
MAUDE report 23619709 ↗
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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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