I-Flow ON-Q Pump Recall Issued for Models With ONDEMAND Bolus Button

Several models of the I-Flow On-Q pain pump have been recalled, due to problems with the ONDEMAND bolus button featured on some devices, which may result in a risk of drug overdose. 

I-Flow Corporation sent a recall notice (PDF) in May 2012 to customers who purchased an On-Q pump with ONDEMAND bolus button. However, the FDA indicated last week that the action has been categorized as a class 1 medical device recall, suggesting that patients face a reasonably probability of serious adverse health consequences or death if the device is used.

The I-Flow On-Q pump recall affects devices manufactured from October 18, 2002 through April 30, 2012, with the ONDEMAND bolus button. The pumps are used for continuous and intermittent delivery of medications, such as local anesthetics or narcotics, to a surgical site before, during or after surgery for anesthetic or pain management.

As a result of problems with some I-Flow On-Q pumps, the ONDEMAND bolus button may not lock down when depressed or may give a false reading on the refill indicator. This could lead to patients being injected with drugs faster than expected, potentially causing a drug overdose or other injuries, including a serious risk of death.

Lawsuits Over I-Flow On-Q Pumps

In recent years, I-Flow Corp. has faced a number of product liability lawsuits over their On-Q pump, involving cases where the device was used following arthroscopic shoulder surgery to deliver certain pain medication directly to the shoulder joint.

Studies have found that such intra-articular use of shoulder pain pumps can lead to the development of chondrolysis, a regenerative disease that causes loss of cartilage in the joint. Symptoms of the condition include a decreased range of motion, pain, as well as popping and grinding of the joint, which tend to develop during the months after use of the pain pump as use of the shoulder increases following the arthroscopic surgery.

Similar shoulder pain pump lawsuits have been filed in state and federal courts throughout the United States against manufacturers of other devices, including Stryker Corp., Breg, DePuy, Inc. and Smith & Nephew, Inc. All of the complaints involve similar allegations that the manufacturers ignored signs that the pain pumps may cause substantial damage to the shoulder joint, continuing to promote intra-articular, despite a failure to obtain FDA approval for such use.