Symbios GOPump Rapid Recovery System kits and GOBlock kits used to relieve pain experienced following surgical procedures are being recalled because of a defect that can cause the device to deliver pain medication too quickly, which could cause serious illnesses including seizures, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications, medical professionals warn.
The GOPump and GOBlock kits are disposable pain management systems that consist of a small balloon that is inflated with a local anesthetic. The medication is delivered slowly through tubes from the balloon to the surgical site. The recall affects all kits assembled prior to July 2012. A listing of all the lot numbers affected can be found here.
Customers who received the devices have been instructed to quarantine the pain pumps in a secure location and complete and return a letter verifying that they have followed the recall request.
This recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is reasonable probability that these products will cause serious adverse health consequences or death.
Any side effects or quality problems with these devices should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch/Report.htm.