FDA Medical Device Recalls (openFDA)
Penumbra Inc.: Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
- Recall number
- Z-0428-2011
- Recalling firm
- Penumbra Inc.
- Product
- Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
- Status
- Terminated
- Initiated
- 2010-10-25
- Posted
- 2010-11-24
- Terminated
- 2011-06-01
- Reason
- Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.
- Root cause
- Process control
- Action
- Penumbra issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to consignees, identifying the affected device and actions to be taken by consignees. Customers were instructed to inspect their inventory for the affected product and quarantine it, pending return to Penumbra. Penumbra employees will contact customers to arrange return and replacement of affected units. Customers were also requested to complete and return a product identification form and return form to Penumbra within 5 business days. Customers can contact Penumbra at 1 510 748-3223 concerning this action.
- Quantity
- 61
- Distribution
- Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.
- Lot, serial or model codes
- Lot number F15020
- 510(k) numbers
- ["K072718"]
- PMA numbers
- not on file
- Product code
- NRY
- 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