KANSAS CITY, MO, October 24, 2009
/24-7PressRelease/ -- On May 29, 2009, the Food and Drug Administration and Penumbra Inc. notified healthcare workers that a Class I recall was beginning for the Penumbra Neuron 5F Select Catheter. Penumbra, Inc. manufactures the catheter in question. This catheter is used to remove foreign objects or blood clots from blood vessels. Those being recalled were manufactured in late May and distributed through June 12.
According to the FDA and Penumbra, Inc., the catheter has a manufacturing error and that pin holes and exposed wires in the catheter may cause a blood vessel puncture or brain clot to form leading to possible death.
The FDA announced through their website that Penumbra, Inc., based in Alameda, California, contacted their customers through telephone and email about the potential risks of the catheter and asked them to return the device. According to the FDA, all defective catheters were returned to Penumbra, Inc. and destroyed.
Class I recalls are the most serious the FDA announces. They are announced when the product has a "reasonable probability" to cause serious injury or death.
Healthcare professionals and consumers who may have been adversely affected by the Neuron 5F Select Catheter have been asked to contact the FDA's MedWatch Adverse Even Reporting Program by email, FAX, or regular mail.
Medical devices are meant to save lives, or at least make them better. However, defects introduced in their manufacture injure and kill people every year. Families are irreparably harmed by circumstances beyond their control that could possibly have been prevented. When this happens, it is important that these families be able to turn to the legal system to get some kind of compensation.
If you or a loved one has been injured, or if you have lost a loved one, due to a defective medical device like the Penumbra 5F Select Catheter, please visit the website of
Schlichter, Bogard & Denton. Schlichter, Bogard & Denton serves clients in the Kansas City, Missouri area, as well as nationwide.
Website:
http://www.druginjuryinformation.com---
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