PINNACLE RSS801Recalls & reported problems
Terumo Medical Corporation · PINNACLE Introducer Sheath · 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 00389701007274), received between Apr 18, 2022 and Apr 18, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
InjuryApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT FLUOROSCOPY REVEALED PART OF THE NON-ABBOTT 6FR SHEATH WAS IDENTIFIED FLOATING IN THE RIGHT ATRIUM. A SNARE RETRIEVAL SYSTEM (UNKNOWN MANUFACTURER) WAS INTRODUCED, AND THE PARTIAL SHEATH WAS RETRIEVED FROM THE PULMONARY ARTERY (WHICH IS WHERE THE SHEATH HAD ADVANCED TO AT THAT POINT). FOLLOWING REMOVAL, ALL DIAGNOSTIC CATHETERS WERE INTACT, AND THE PHYSICIAN LEFT THE ROOM. THEN, THE OPERATING PHYSICIAN TRIED TO INTRODUCE A NEW NON-ABBOTT 8F SHEATH INTO THE GROIN, AT WHICH IT WAS OBSERVED THAT THIS NEW SHEATH ALSO WAS SEVERED AND LEFT A PARTIAL SEGMENT INSIDE THE RIGHT FEMORAL VEIN. THE OTHER PHYSICIAN WAS NOTIFIED AND CAME BACK AND USED ANOTHER SNARE RETRIEVAL SYSTEM (MANUFACTURER UNKNOWN) FROM THE LEFT GROIN TO RETRIEVE THE 8F SEGMENT FROM THE RIGHT SIDE. THERE WAS SUCCESSFUL RETRIEVAL OF SAID SHEATH SEGMENT AND THE REST OF THE CIRCULATORY SYSTEM OF PATIENT WAS OBSERVED UNDER FLUOROSCOPY TO MAKE SURE THAT THERE WERE NO REMAINING FRAGMENTS/SEGMENTS OF SHEATH IN THE BODY. THE PROCEDURE WAS THEN ABORTED, AND ALL REMAINING SHEATHS REMOVED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE WITH NO COMPLICATIONS OR ADVERSE EVENTS/OUTCOMES. ADDITIONAL INFORM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14136160 ↗
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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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