The FDA has issued a Class I recall, it’s highest classification, for all lots of GOPumps in the GoPump Rapid Recovery System kits and GOBlock kits manufactured with flow control components before 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.
The recall has been issued because 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.
Customers who have purchased the affected devices should have received a 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. The letters included directions to quarantine the product in a secure location and complete and return a verification form included in the letter.
The product’s US distributor, B.Braun Medical, itself issued a customer notification on May 14, 2013. This notification directed customers to return products.
Class I 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 adverse health consequences or death.
Affected LOTs can be found listed on the recall notice, here.