Z-2049-2009

Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by...

Name: Z-2049-2009 Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by...
Creator: Penumbra Inc.
Published: 2009-07-02
License: https://open.fda.gov/license/

Penumbra Inc. / initiated 2009-07-02 / Terminated / root cause: manufacturing process

FDA source

Penumbra Inc. began a recall of Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the... on 2009-07-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2049-2009
Status: Terminated
Initiated: 2009-07-02
Posted: 2009-09-08
Terminated: 2011-01-05
Recalling firm: Penumbra Inc.
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.
Product code: DQY Catheter, Percutaneous
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 9 units
Distribution: Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
Product codes and lots: Catalog Number: PNS5f130H1; Lot Number: F15174.

Product code DQY

K083125Class IINeuron Select Catheter Size 070Penumbra, Inc. / cleared 2008-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)