Penumbra Catheter Recall Issued for Neuron 6F 070 Delivery Catheter

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Older versions of Penumbra Inc.’s Neuron 6F 070 Delivery Catheter have been recalled in the wake of reports that some catheters have kinked, ovalized or broken, resulting in injuries.

The Penumbra Neuron delivery catheter recall was announced September 29 and affects 31 lots of the original versions of the catheters. If the catheters kink or collapse when bent, it could result in waste not being removed from the patient, potentially resulting in life-threatening complications.

A kinked or ovalized catheter can restrict the flow of material through the catheter, cause problems with the insertion of other devices through the guide catheter, and can lead to the catheter breaking after continued use.

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Only the original versions of the Neuron 6f 070 Delivery Catheters are being recalled. The recall affects products with the catalog numbers PND6F0701058, PND6F0701058M, PND6F070956 and PND6F070956M, and with the 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.

The recall does not affect catheters with lot numbers F14630 or higher.

Anyone using a recalled Neuron 6F 070 Delivery Catheter should stop using the device and return it for a replacement. Penumbra has notified hospitals who bought the devices through the use of notification letters.

Tags: Catheter Recall, Neuron Delivery Catheter, Penumbra Catheter
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