The FDA gave Class I status to the massive recall of Symbios pain management products, meaing the federal watchdog agency believes the devices could cause serious injury or death.
Symbios last month warned that components of its pain management kits made before July 2012 could deliver dangerously high drug-release flow rates, meaning patients could be poisoned by rapid medication influx.
The devices – GOPumps in the GoPump Rapid Recovery System kits and GOBlock kits – use a balloon to deliver pain medication inside the body.
The warning is especially relevant to elderly and small patients, who are at higher risk of illness, seizure, abnormal heart rhythm and death, according to the FDA.
Indianapolis, Ind.-based Symbios said in May that all lots that came off the shelves before July 2012 and were delivered between April 2011 and April 2013 may be affected.