Penumbra Coil 400 4002C0512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244002C05120), received between Sep 1, 2015 and Apr 6, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400''S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FIVE PC400'S INTO THE TARGET VESSEL USING A NON-PENUMBRA CATHETER AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). THE PHYSICIAN THEN HAD DEPLOYED A SIXTH PC400 (LOT # A25537) INTO THE PATIENT BUT HAD DIFFICULTY DETACHING THE COIL USING THE SAME HANDLE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO DETACH THE COIL. NEXT, THE PHYSICIAN DEPLOYED A SEVENTH PC400 (LOT # F70957) INTO THE PATIENT AND ATTEMPTED TO DETACH THE COIL USING THE SAME HANDLE. HOWEVER, AFTER SEVERAL ATTEMPTS, THE PC400 WAS UNABLE TO DETACH AND WAS REMOVED. THEREAFTER, THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6465475 ↗
• MalfunctionSep 1, 2015Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SUPERIOR GLUTEAL ARTERY USING PENUMBRA COIL 400 (PC400) COILS. DURING THE PROCEDURE, A PC400 COIL WAS SUCCESSFULLY DEPLOYED INTO THE ANEURYSM; HOWEVER, THE PC400 COIL WOULD NOT DETACH USING A PENUMBRA COIL 400 DETACHMENT HANDLE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN REPOSITIONED THE MICROCATHETER, BUT THE PC400 COIL WOULD NOT DETACH. THE PC400 COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE CONTINUED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5047948 ↗

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 · Terminated
  Penumbra 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