Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
FDA Recall Z-0428-2011 · Posted 2010-11-24
Recalling FirmPenumbra Inc.
Recall StatusTerminated
Product CodeNRY
Date Initiated2010-10-25
Date Terminated2011-06-01
Product Quantity61
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.