FDA Device Recall Z-0001-2010: Penumbra Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2010.

Recall Res Number

Z-0001-2010

Recalling Firm / Manufacturer

Penumbra Inc.

FEI Number

3005168196

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-09-22

Date Posted

2009-10-05

Date Terminated

2010-11-24

Product Code

DQY

Event Number

53426

Product Quantity

2246 units

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.

Reason for Recall 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.

Action Details 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.

Distribution Pattern Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.

Code Information / 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.

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Medical Device Recall: Z-0001-2010

Recall Parameters & Description

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