Penumbra Neuron 5F Select Catheter, Neuro… recallZ-2049-2009 · Penumbra Inc. · initiated Jul 2, 2009
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Penumbra Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2049-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 2, 2009
- Posted by the FDA
- Sep 8, 2009
- Recalling firm
- Penumbra Inc.
- Quantity
- 9 units
- Product code
- DQY
- FDA submissions
- K083125
- Distribution
- Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
Product description
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.
Code information (models, lots, serial numbers)
Catalog Number: PNS5f130H1; Lot Number: F15174.
Other devices under the same FDA submission
8 devices cleared under K083125 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Neuron PNS5F130SIMPenumbra, Inc. · CATHETER, PERCUTANEOUS1 death24 reports
- Neuron PNS5F130BERPenumbra, Inc. · CATHETER, PERCUTANEOUS14 reports
- Neuron PNS5F120BERPenumbra, Inc. · CATHETER, PERCUTANEOUS1 death6 reports
- Neuron PNS5F130H1Penumbra, Inc. · CATHETER, PERCUTANEOUS4 reports
- Neuron PNS5F120SIMPenumbra, Inc. · CATHETER, PERCUTANEOUS3 reports
- Neuron PNS5F130SIM-RPenumbra, Inc. · CATHETER, PERCUTANEOUS2 reports
- Neuron PNS5F120H1Penumbra, Inc. · CATHETER, PERCUTANEOUS1 report
- Neuron PNS5F130BER-RPenumbra, Inc. · CATHETER, PERCUTANEOUS1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page