FDA and Symbios Medical Products are informing the public of a recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012.
The Symbios GOPump Rapid Recovery System is a disposable local pain management system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered slowly through tubes from the balloon to the surgical site. According to Symbios, the GOPump “attaches to the catheter and automatically directs local anesthetic to the pain source, dulling the pain and reducing or eliminating the need for additional painkillers or narcotics.”
According to the recall notice, the affected products may have “excessively high flow rates.” As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness, including seizure, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications.
To date the company has reported 5 complaints about the pumps, 2 of which involved serious consequences. No patient deaths have been reported thus far. A listing of all the lot numbers affected is available at the FDA’s website.
According to the FDA, customers who have purchased the affected devices were notified by letter dated May 10, 2013 about the problem. Follow-up letters were sent on May 14, 2013 and May 30, 2013 notifying customers of additional recalled lots. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
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The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions. As a result, we have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. We have represented hundreds of people regarding dangerous fentanyl pain patches, defective hip and knee implant devices, Yaz, Actos, Avandia and Accutane—to name just some examples.
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At Heygood, Orr & Pearson, we believe that when a drug company sells a drug or medical device that is dangerous and unsafe, they should be held responsible for the damage. In addition, we have the resources and experience to protect a person’s rights and the rights of their loved ones against irresponsible pharmaceutical companies and medical device manufacturers.
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* Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.