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.
Read the complete MedWatch 2009 Safety summary, including a link to the firm Press Release.
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.
Read the complete MedWatch 2009 Safety summary, including a link to the firm Press Release.
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