Penumbra Coil 400 4002C1145-ARecalls & reported problems
Penumbra, Inc. · Coil 400 Standard, 11x45 · Class 2
All models of Penumbra Coil 400 (120)
Data updated Oct 18, 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 00814548019178), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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 18, 2026.
Most reported problems
Device problems
- Premature Separation1
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.
MalfunctionJul 21, 2023Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S), PAC400S, NON-PENUMBRA COILS, AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS. WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE COIL UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE PC400 WAS REMOVED FROM THE PATIENT AND THE PC400 WAS THEN REMOVED FROM THE PX SLIM. THE PROCEDURE WAS COMPLETED USING NINE COILS (PENUMBRA AND NON-PENUMBRA COILS) AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17372272 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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