Penumbra Coil 400 4002C0412Recalls & reported problems
Penumbra, Inc. · PC400 Cplx Std, 4x12 · 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 M4244002C04120), received between Aug 21, 2015 and Aug 21, 2015 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or 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 18, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2015Activation, Positioning or Separation Problem
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID ARTERY USING A PENUMBRA COIL 400 (PC400 COIL). DURING THE PROCEDURE, THE PC400 COIL BECAME STRETCHED WHILE DEPLOYING INTO THE ANEURYSM. THE PHYSICIAN SUCCESSFULLY REMOVED THE DAMAGED COIL BY REMOVING THE MICROCATHETER AND PC400 COIL TOGETHER. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER MANUFACTURER'S DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5023055 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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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