FDA Medical Device Recalls (openFDA)
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 number
- Z-2049-2009
- 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.
- Status
- Terminated
- Initiated
- 2009-07-02
- Posted
- 2009-09-08
- Terminated
- 2011-01-05
- Reason
- 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
- 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
- 9 units
- Distribution
- Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
- Lot, serial or model codes
- Catalog Number: PNS5f130H1; Lot Number: F15174.
- 510(k) numbers
- ["K083125"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3005168196
- Firm city
- Alameda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28