Z-0428-2011

Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by...

Name: Z-0428-2011 Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by...
Creator: Penumbra Inc.
Published: 2010-10-25
License: https://open.fda.gov/license/

Penumbra Inc. / initiated 2010-10-25 / Terminated / root cause: manufacturing process

FDA source

Penumbra Inc. began a recall of Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA on 2010-10-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0428-2011
Status: Terminated
Initiated: 2010-10-25
Posted: 2010-11-24
Terminated: 2011-06-01
Recalling firm: Penumbra Inc.
Product: Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot number F15020

Product code NRY

K072718Class IIPenumbra SystemPenumbra, Inc. / cleared 2007-12-28

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)