Penumbra Coil 400 4006C0404Recalls & reported problems
Penumbra, Inc. · PC400 Cplx XSft, 4x4 · Class 2 · Implant
All models of Penumbra Coil 400 (120)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244006C04040), received between Oct 9, 2020 and May 21, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Material Twisted/Bent1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, A PC400 BECAME STUCK IN THE PX SLIM WHILE ADVANCING IT TOWARDS THE TARGET VESSEL. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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 11867000 ↗MalfunctionOct 9, 2020Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PC400 WITHIN ITS INTRODUCER SHEATH, THE PC400 WOULD NOT ADVANCE PAST THE FRICTION LOCK AND INADVERTENTLY, THE PUSHER ASSEMBLY OF THE PC400 BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10659047 ↗
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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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