Pain Pump Recalled

An Indiana-based medical device maker is recalling its portable pain pumps, telling patients the devices could malfunction and dispense more pain medicine than expected.

On February 25, 2013, Symbios Medical Products voluntarily informed customers of problems with its GOPump infusion pump kit. Symbios instructed customers to stop using the devices and send them back to the company.

In March, the U.S. Food and Drug Administration (FDA) affixed its Class 1 tag to the Symbios recall effort, a serious label warning users of a product that has the potential for injury or death.

Symbios’ pain pumps deliver non-narcotic pain medicine via catheter to a specific part of the body. The company claims the pumps can reduce and sometimes even eliminate the need for narcotics. Surgeons program the devices that typically are implanted after surgery. According to the FDA, Symbios told patients that the pump’s flow-restrictor bead could dislodge and release pain medication at a higher rate than what is programmed. The pumps are designed to dispense calibrated doses on a set schedule although some pumps can be activated on demand.

The recall could be a blow for Symbios. In late 2010, the company was selling nearly 6,000 pumps a year according to published reports. The reports say that last year the medical device maker put together plans to raise close to $7 million. Company officials say the idea behind its GOPump device is to decrease the use of narcotics and improve post-surgery recovery.

The flagship GOPump is tiny enough to be hooked to a belt. It delivers a local anesthetic to an incision site for several days after surgery. The company’s follow-up product, the GOBlock, provides pain medication for up to six days without doctor supervision after the initial setup. Both patients and doctors can observe the anesthesia’s progress through the pump’s transparent shell.

The disposable pump kits in the recall, part number 510076, operate with a pair of 150 ml inflatable reservoirs, each connected to a separate catheter. The pump kits were distributed between September 2012 and February 2013. Symbios is asking customers to discontinue use of the product, fill out a verification form and return the product to the manufacturer.

Additional Resources:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm344311.htm