Penumbra Coil 400 4002C0312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M4244002C03120), received between Oct 5, 2017 and Jun 22, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 OUT OF THE TIP OF THE INTRODUCER SHEATH AND INTO THE HUB OF A LANTERN DELIVERY MICROCATHETER (LANTERN), DESPITE ATTEMPTING MULTIPLE TIMES. THE PHYSICIAN REMOVED THE PC400 AND ATTEMPTED TO ADVANCE IT OUT OF THE INTRODUCER SHEATH ON THE BACK TABLE, HOWEVER WAS UNABLE TO DESPITE ATTEMPTING MULTIPLE TIMES AND FLUSHING THE PC400. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW PC400 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 7631738 ↗
• MalfunctionJan 3, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), AND THEREFORE THE PC400 WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING 6 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 7163086 ↗
• MalfunctionDec 27, 2017Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) TO TREAT TYPE II ENDOLEAK USING PENUMBRA COILS 400 (PC400S). IT WAS REPORTED THAT THE PATIENT ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND ONE PC400 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE RIGHT AFTER INSERTING THE PC400 INTO THE MICROCATHETER AND THE PC400 BECAME STUCK; THEREFORE IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149453 ↗
• MalfunctionOct 5, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HEPATIC ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 THROUGH THE HUB OF A NON-PENUMBRA MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO NON-PENUMBRA COILS USING THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400, HOWEVER AGAIN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THROUGH THE HUB OF THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE PC400 AND MICROCATHETER, AND FLUSHED THE MICROCATHETER. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND RE-ATTEMPTED TO ADVANCE THE TWO PC400S, BUT WAS STILL UNABLE TO. THE PROCEDURE WAS THEREFORE COMPLETED USING THE SAME MICROCATHETER, NEW PC400S, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6918001 ↗

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