Penumbra Coil 400 4002C1030-ARecalls & reported problems
Penumbra, Inc. · Coil 400 Standard, 10x30 · Class 2
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 00814548019147), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Physical Resistance/Sticking1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2023Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SIGMOID SINUS USING A PENUMBRA COIL 400 (PC400), A POD400 COIL (POD400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400, THE HOSPITAL TECHNICIAN KINKED THE PUSHER ASSEMBLY OF THE PC400; HOWEVER, THE PHYSICIAN CONTINUED TO ADVANCE THE PC400. SUBSEQUENTLY, THE PHYSICIAN ENCOUNTERED RESISTANCE AND KINKED THE PUSHER ASSEMBLY AT THE SAME LOCATION. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE PC400 AND THE PC400 UNINTENTIONALLY DETACHED PARTIALLY IN THE PX SLIM AND PARTIALLY IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED THE POD400 THROUGH THE PX SLIM AND ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE PC400 WAS PARTIALLY DEPLOYED IN THE PX SLIM AND WAS CAUSING THE RESISTANCE FOR THE POD400. THEREFORE, THE POD400 WAS REMOVED AND PC400 WAS PUSHED TO THE TARGET LOCATION BY USING THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A NEW POD400 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 16588458 ↗
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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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