Z-2313-2009

Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA...

Name: Z-2313-2009 Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA...
Creator: Penumbra Inc.
Published: 2009-07-01
License: https://open.fda.gov/license/

Penumbra Inc. / initiated 2009-07-01 / Terminated / root cause: labeling and UDI

FDA source

Penumbra Inc. began a recall of Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of... on 2009-07-01. The reason FDA records is "Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2313-2009
Status: Terminated
Initiated: 2009-07-01
Posted: 2009-09-24
Terminated: 2010-11-30
Recalling firm: Penumbra Inc.
Product: Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
Product code: DQY Catheter, Percutaneous
Reason for recall: Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.
Quantity in commerce: 37 units
Distribution: CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.
Product codes and lots: Catalog number PND6F11512M, lot number F14751

Product code DQY

K070970Class IINeuron Support Catheter System, Model 5F/6fPenumbra, Inc. / cleared 2007-08-17

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)