Neuron PNMD8F088904MRecalls & reported problems
Penumbra, Inc. · NeurMAX088, 90MP · Class 2
All models of Neuron (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548012308), received between Apr 28, 2016 and Apr 28, 2016 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Atrial Fibrillation1
- Infarction, Cerebral1
- Reocclusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER, A VELOCITY DELIVERY MICROCATHETER, A NEURON MAX 8F 088 DELIVERY CATHETER AND A NEURON 6F SELECT CATHETER AND COMPLETE RECANALIZATION OF THE TARGET VESSEL WAS ACHIEVED. HOWEVER, AFTER THE PROCEDURE THE PATIENT WENT INTO ATRIAL FIBRILLATION (A-FIB) AND WAS IMMEDIATELY GIVEN 25 MG OF IV CARDIZEM BEFORE BECOMING HYPOTENSIVE. ON POSTOPERATIVE DAY 1 ((B)(6) 2014), A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AS A ROUTINE FOLLOW-UP. UPON RETURN, THERE WAS ABNORMAL EXTENSION IN THE PATIENT'S RIGHT UPPER EXTREMITY (RUE) AND DIMINISHED CORNEAL. THE MRI SCANS DEMONSTRATED LARGE AREAS OF ACUTE/SUBACUTE INFARCTION IN THE LEFT CEREBRAL HEMISPHERE, PREDOMINANTLY IN THE MIDDLE CEREBRAL ARTERY (MCA) DISTRIBUTION, BUT ALSO WITHIN THE ANTERIOR CEREBRAL ARTERY (ACA) AND POSTERIOR CEREBRAL ARTERY (PCA) DISTRIBUTIONS. A MAGNETIC RESONANCE ANGIOGRAM (MRA) DEMONSTRATED OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY (ICA) AND MCA. LATER, ON THE SAME DAY ((B)(6) 2014), A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) WAS PERFORMED AND SHOWED SUBACUTE LEFT MCA INF
Patient problems: Atrial Fibrillation; Infarction, Cerebral; Reocclusion
MAUDE report 5618295 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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