Penumbra Coil 400 4002C0415Recalls & reported problems
Penumbra, Inc. · PC400 Cplx Std, 4x15 · 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 M4244002C04150), received between Aug 7, 2019 and Aug 7, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (1 report).
1 other recall cover devices cleared under the same FDA submission (K103305); they may or may not involve this specific model.
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
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact 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 7, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A PC400 THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AFTER ADVANCING A LOOP OF THE PC400 OUT OF THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE PC400; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN ALONG WITH THE PC400 FROM THE PATIENT AND REMOVED THE PC400. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PC400S AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8872068 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103305. One submission often covers many models, so check the product and lot details in each record.
- Z-1906-2011 · Mar 4, 2011 · TerminatedPenumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is in
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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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