Penumbra Coil 400 4002C0615Recalls & reported problems
Penumbra, Inc. · PC400 Cplx Std, 6x15 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244002C06150), received between Sep 30, 2015 and Dec 21, 2015 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Infarction, Cerebral1
- Neurological Deficit/Dysfunction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2015Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT POSTERIOR INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SIX PC400 COILS INTO THE ANEURYSM WITH NO IMMEDIATE COMPLICATIONS USING THE PX SLIM. THE FOLLOWING DAY, THE PATIENT EXPERIENCED A SEVERE RIGHT POSTERIOR LIMBIC STROKE. THE EVENT REMAINED UNRESOLVED AND NO ACTIONS WERE TAKEN. THE REPORTED RIGHT POSTERIOR LIMBIC STROKE WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS AND A POSSIBLE RELATIONSHIP TO THE PX SLIM, ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM STATE.
Patient problems: Neurological Deficit/Dysfunction
MAUDE report 5316940 ↗InjurySep 30, 2015Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ANTERIOR CEREBRAL ARTERY (ACA)-ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THIRTEEN PC400 COILS WERE SUCCESSFULLY DEPLOYED AND DETACHED INTO THE ANEURYSM WITH NO COMPLICATIONS. APPROXIMATELY 3 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED A SEVERE ISCHEMIC STROKE IN THE LEFT ANTERIOR CEREBRAL ARTERY. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA), MAGNETIC RESONANCE IMAGING (MRI), ELECTROENCEPHALOGRAM (EEG), TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE PERFORMED AND THE PATIENT WAS TREATED WITH SIMVASTATIN. THE REPORTED ISCHEMIC STROKE RESOLVED ON (B)(6) 2013.
Patient problems: Infarction, Cerebral
MAUDE report 5114246 ↗
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- 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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