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U.S. Department of Health and Human Services

Safety

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Neuron 6F 070 Delivery Catheter [Penumbra]

Voluntary Field Removal
Audience: interventional neuroradiology healthcare professionals, hospital risk managers

[UPDATED 10/07/2009] Recall classified as Class I.

[Posted 10/01/2009] Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death. There are four injury reports to date, which may be potentially associated with this defect.

Facilities that have the older version of 6F Neuron 070 Delivery Catheter which is being recalled should stop using and return the device.  Penumbra is notifying affected hospitals through detailed Field Removal notification letters requesting that affected product be returned to Penumbra. The affected product catalog numbers and lot numbers are provided in the firm press release.

[10/07/2009 - Recall Notice - FDA]

[09/29/2009 - Press Release - Penumbra]