PINNACLE RSS606Recalls & reported problems
Terumo Medical Corporation · PINNACLE Introducer Sheath · Class 2
Data updated Oct 13, 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 00389701007717), received between Nov 21, 2019 and Nov 21, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THE USER FACILITY REPORTED THAT A BOSTON SCIENTIFIC 6 MM X 20 MM PERIPHERAL CUTTING BALLOON WAS DELIVERED THROUGH A 6 FR 25 CM PINNACLE SHEATH TO RIGHT POPLITEAL ARTERY. POPLITEAL ARTERY WAS TREATED WITH BALLOON ANGIOPLASTY. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS IN STABLE CONDITION. WHEN THE SHEATH WAS PULLED POST PROCEDURE, IT WAS NOTICED THAT THE SHEATH WAS CUT LONGITUDINALLY ALONG THE SHEATH SHAFT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9353646 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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