Device recall

Z-0001-2010: Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers…

FDA device recall · Class I · Penumbra Inc.

Key facts

Recall number (Z-number) Z-0001-2010
Recall event 53426
Product 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.
Product code DQY
Recalling firm Penumbra Inc.
Recall class Class I
Status Terminated
Termination date Nov 24, 2010
510(k) numbers K082290
FEI number 3005168196

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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