Penumbra Inc. Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
Brand
Penumbra Inc.
Lot Codes / Batch Numbers
Catalog Number: PNS5f130H1, Lot Number: F15174.
Products Sold
Catalog Number: PNS5f130H1; Lot Number: F15174.
Penumbra Inc. is recalling Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured due to Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may resu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
Recommended Action
Per FDA guidance
Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra. For further information, contact Penumbra, Inc. at 1-510-748-3223.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IA, NJ, NY, VA
Page updated: Jan 10, 2026