Penumbra Announces Worldwide Voluntary Field Removal of the Original Version of 6F Neuron 070 Delivery Catheter

Wednesday, September 30th, 2009

- September 29, 2009 - ALAMEDA, CA - (BUSINESS WIRE)- Penumbra is initiating a voluntary Field Removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can 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.

Consumers who have the older version of 6F Neuron 070 Delivery Catheter which is being recalled should stop using and return the device. If your facility is in possession of units with Lot numbers F14630 or higher, you may continue to use these units. Units with Lot numbers F14630 or higher are not affected by this Field Removal Action.

The following product catalog numbers and Lot numbers are affected by this Field Removal. Neuron Delivery Catheter 070 catalog number: PND6F0701058, PND6F0701058M, PND6F070956 and PND6F070956M. Affected Lot numbers include: 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.

Penumbra voluntarily conducted a field removal of the devices after learning about the devices potential to kink or ovalize. FDA has been apprised of this action.

There are four injury reports to date, which may be potentially associated with this defect.

Penumbra is notifying affected hospitals through detailed Field Removal notification letters requesting that affected product be returned to Penumbra. Replacement product will be available for all affected customers. Consumers with questions may contact Penumbra directly at 1-888-272-4606 or 510-748-3200.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online:www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178