Neuron PNS5F130BER-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948027893), received between Aug 26, 2026 and Aug 26, 2026 — classified as 1 death.

The most frequently reported specific device problem is “Fracture” (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.

• DeathAug 26, 2026Fracture

  The patient was undergoing a thrombectomy procedure in the M1 segment of the middle cerebral artery (MCA) using a Neuron Select Catheter 5F (5F Select). The physician was advancing the 5F Select in the cervical area and reported that it fractured on the distal length in the common carotid artery (CCA). Several attempts were made to retrieve the fractured segment of the 5F Select using a snare device; however, they were unsuccessful. A balloon device was then used; however, the fractured segment migrated distally. The physician decided to continue the thrombectomy procedure using a stent retriever.After the thrombectomy was completed, the physician found that the 5F Select segment had broken into several smaller fragments. Further attempts were made to retrieve the remaining 5F Select fragments, without success. Some fragments remained in the internal carotid artery (ICA). The physician decided to terminate the procedure at this point.It was reported that the patient expired the following day on (b)(6) 2026. The cause of death is unknown.

  Patient problems: Foreign Body In Patient

  MAUDE report 50453404 ↗

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