Neuron PNS5F120H1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548010199), received between Aug 24, 2016 and Aug 24, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K083125); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2016Break; Detachment Of Device Component; Break; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TREATING AN ABDOMINAL AORTIC ANEURYSM ENDOLEAK (AAA ENDOLEAK) USING A NEURON 5F SELECT CATHETER (5F SELECT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 5F SELECT THROUGH ANOTHER MANUFACTURER'S SHEATH WITHOUT EXPERIENCING RESISTANCE. HOWEVER, WHILE TORQUING THE 5F SELECT INTO THE RIGHT COMMON ILIAC ARTERY, THE HOSPITAL TECHNOLOGIST BELIEVED THAT THERE WAS A KINK IN THE 5F SELECT. THEREFORE, THE PHYSICIAN STEPPED BACK ONTO FLUOROSCOPY AND NOTICED THAT THE ENTIRE BLACK TIP OF THE 5F SELECT HAD SEPARATED FROM THE REST OF THE CATHETER AND WAS FLOATING IN THE AORTA. THE PHYSICIAN THEN IMMEDIATELY WITHDREW THE 5F SELECT AND REMOVED THE INTACT DETACHED TIP FROM THE PATIENT USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT, MULTIPLE OTHER CATHETERS AND THE SAME SHEATH. IT WAS REPORTED THE PATIENT'S ANATOMY WAS TORTUOUS WHICH THE PHYSICIAN BELIEVED MAY HAVE CAUSED THE 5F SELECT TO BREAK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5901513 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083125. One submission often covers many models, so check the product and lot details in each record.

• Z-2049-2009 · Jul 2, 2009 · Terminated
  Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional