Penumbra Coil 400 4004C0513-ARecalls & reported problems
Penumbra, Inc. · Coil 400 Soft, 5x13 · 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 00814548018461), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Premature Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Fracture; Premature Separation; Fracture; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ARTERIOVENOUS (AV) FISTULA ARTERY USING PENUMBRA COILS 400 (PC400), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AN ACCESS25 DELIVERY MICROCATHETER (ACCESS25), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 TO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN DETERMINED THE PC400 WAS UNDERSIZED AND DECIDED TO RESHEATH THE PC400. THE PC400 BECAME KNOTTED AND WHILE RETRACTING, THE EMBOLIZATION COIL DETACHED. MANUAL SUCTION AND DUAL SNARES WERE USED TO ATTEMPT TO REMOVE THE EMBOLIZATION COIL WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO LEAVE THE EMBOLIZATION COIL IN THE INTERNAL ILIAC VEIN. IT WAS REPORTED THAT THE EMBOLIZATION COIL MIGRATED TO THE LUNG. NO INTERVENTION WAS PERFORMED TO REMOVE THE EMBOLIZATION COIL. THERE WERE NO ADDITIONAL ADVERSE EVENTS CAUSED BY LEAVING THE DETACHED COIL IN LUNG. THE PHYSICIAN ADVANCED ANOTHER PC400 INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE PC400 USING A HANDLE. THE PUSHER ASSEMBLY OF THE PC400 HAD SEPARATED, BUT THE EMBOLIZATION COIL DID NOT DETACH. THE PHYSICIAN THEN PUSHED THE PC400 INTO THE TARGET LOCATION USING THE PUSHER ASSEMBLY AND IT EV
Patient problems: Foreign Body In Patient
MAUDE report 22344509 ↗
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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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