Penumbra Coil 400 4004C0710Recalls & reported problems
Penumbra, Inc. · PC400 Cplx XSft, 7x10 · 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 M4244004C07100), received between Nov 17, 2015 and Aug 23, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Failure to Fold1
- Flushing Problem1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2019Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE PC400 INTO THE ANEURYSM. IT WAS ALSO REPORTED THAT THE PC400 WOULD NOT ADJUST TO THE INTENDED SHAPE WITHIN THE ANEURYSM. THE PC400 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8925605 ↗MalfunctionNov 17, 2015Flushing Problem; Device Difficult to Setup or Prepare; Failure to Advance
DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, AFTER REMOVING A PENUMBRA COIL 400 COIL (PC400 COIL) FROM ITS PACKAGING, THE HOSPITAL STAFF WAS UNABLE TO ADVANCE THE PC400 COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LIQUID BATH (HEPARINIZED SALINE). THE HOSPITAL STAFF INDICATED THAT THERE WAS NO RESISTANCE ON THE PC400 COIL PUSHER ASSEMBLY AND NO REPORTED DAMAGE TO THE PUSHER ASSEMBLY. THE PC400 COIL WAS UNABLE TO BE FLUSHED FOR USE AND WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A NEW PC400 COIL.
Patient problems: No Patient Involvement
MAUDE report 5230396 ↗
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- 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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