Penumbra Coil 400 4004C0935Recalls & reported problems
Penumbra, Inc. · PC400 Cplx XSft, 9x35 · 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 M4244004C09350), received between Aug 21, 2015 and Dec 21, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or 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 or Device Component1
- Failure to Advance1
- Physical Resistance/Sticking1
- Stretched1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
MalfunctionDec 21, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 INTO THE MICROCATHETER, THE PC400 WAS STUCK AND WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8191274 ↗MalfunctionAug 21, 2015Stretched; Detachment of Device or Device Component
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 (PC400) COILS. DURING THE PROCEDURE, THE PC400 COIL BECAME STRETCHED WHILE DEPLOYING INTO THE ANEURYSM. UPON RETRACTION, THE PC400 COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN REQUIRED A SNARE DEVICE TO REMOVE THE DETACHED PC400 COIL; HOWEVER A FRAGMENT OF THE PC400 COIL REMAINED IN THE PATIENT AND WAS SECURED USING A STENT DEVICE. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5023070 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
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- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- 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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