Penumbra Coil 400 4002C0915Recalls & reported problems
Penumbra, Inc. · PC400 Cplx Std, 9x15 · Class 2 · Implant
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 M4244002C09150), received between May 6, 2016 and May 6, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of 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 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
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.
MalfunctionMay 6, 2016Detachment Of Device Component; Detachment Of Device Component
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 UNINTENTIONALLY DETACHED WITH PART OF THE COIL REMAINING INSIDE OF THE PX SLIM AND THE OTHER PART OF THE COIL OUTSIDE OF THE PX SLIM. IN AN ATTEMPT TO PUSH THE DETACHED PC400 OUT OF THE PX SLIM COMPLETELY AND INTO THE TARGET VESSEL, THE PHYSICIAN ADVANCED A NEW PC400 THROUGH THE PX SLIM; HOWEVER, THE NEW PC400 DETACHED AS WELL. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE TWO DETACHED PC400 COILS IN THE TARGET VESSEL BY USING A NEW PC400; HOWEVER, THE NEW PC400 DETACHED WHILE BEING ADVANCED THROUGH THE PX SLIM. THE SAME SCENARIO HAPPENED WITH A NEW (FOURTH) PC400. FINALLY, THE PHYSICIAN SUCCESSFULLY PUSHED ALL FOUR DETACHED PC400 COILS OUT OF THE PX SLIM AND INTO THE TARGET VESSEL USING A NEW PC400. THE PROCEDURE WAS COMPLETED USING THAT PC400 AND TWO ADDITIONAL PC400 COILS AND THE SAME PX SLIM USED THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5638088 ↗
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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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