[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.
Penumbra, Inc. Neuron 6F 070 Delivery Catheter (Original Version)
This product was distributed from November 2008 to May 2009.
The Neuron 6F 070 Delivery Catheter is a component of the Neuron Intracranial Access System, which is used by physicians to introduce medical devices into blood vessels.
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, California 94502-6541
Reason for Recall:
The device may kink and/or break which may lead to longer surgery times, patient injury or death.
Consumers may contact the company at 1-888-272-4606 or 1-510-748-3200, Monday - Friday, 8 AM to 5 PM Pacific Time.
For more information, see Useful Links below.
On September 22, 2009, the company sent their customers a field removal letter requesting that they inspect their stock, remove all affected devices and return them to the company. The company will replace the affected devices. The company also asked their customers to complete and sign a product identification/return form.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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