Penumbra Neuron Delivery Catheter 070, percutaneous… recallZ-0001-2010 · Penumbra Inc. · initiated Sep 22, 2009
Terminated All recalls posted in October 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
Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.
FDA root cause category: Device Design
What the company is doing
The firm issued an Urgent Voluntary Field Removal Notice letter on 09/22/2009 to its consignees, asking them to inspect their stocks; remove affected product and place in quarantine for return to Penumbra Inc.; and complete and return the attached product identification / return form.
Recall details
- Recall number
- Z-0001-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 22, 2009
- Posted by the FDA
- Oct 5, 2009
- Recalling firm
- Penumbra Inc.
- Quantity
- 2246 units
- Product code
- DQY
- FDA submissions
- K082290
- Distribution
- Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.
Product description
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Code information (models, lots, serial numbers)
Lot numbers F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, F14183, F14427, F14482, F14560, and F14629.
Other devices under the same FDA submission
9 devices cleared under K082290 — 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 PND6F0701058MPenumbra, Inc. · CATHETER, PERCUTANEOUS38 reports
- Neuron PND6F070956MPenumbra, Inc. · CATHETER, PERCUTANEOUS25 reports
- Neuron PND6F0701058Penumbra, Inc. · CATHETER, PERCUTANEOUS17 reports
- Neuron PND6F070956Penumbra, Inc. · CATHETER, PERCUTANEOUS6 reports
- Neuron PND6F1056MPenumbra, Inc. · CATHETER, PERCUTANEOUS5 reports
- Neuron PND6F10512Penumbra, Inc. · CATHETER, PERCUTANEOUS2 reports
- Neuron PND6F1156MPenumbra, Inc. · CATHETER, PERCUTANEOUS2 reports
- Neuron PND6F1056Penumbra, Inc. · CATHETER, PERCUTANEOUS1 report
- Neuron PND6F11512Penumbra, Inc. · CATHETER, PERCUTANEOUS1 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.
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