Diabetics have traditionally had to give themselves daily injections of insulin via syringes or insulin pens. Insulin pumps provide diabetics with a much more convenient method of insulin delivery. Unfortunately, there have been a growing number of insulin pump related recalls.  Just last year, the FDA issued a recall of the Medtronic Insulin Pump after the company determined that approximately 60,000 infusion sets used within the pumps were defective.  Because of air pressure problems, the defective pumps supplied too much insulin, not enough insulin, or no insulin at all. Medtronic has issued a recall of approximately three million Medtronic Insulin Pumps to date, due to the air pressure defect.

Serious Injuries Resulting From Faulty Medtronic Insulin Pumps

The defective pumps caused serious injury and death, most resulting from hypoglycemia.  The FDA reported more than 29 cases of car accidents associated with the Medtronic Insulin Pump malfunctions.  Some patients died while driving; other patients lost consciousness while driving, causing them to crash into other vehicles or drive off the road, ending up in lakes, or even slam into buildings at high speed. 

Medtronic criticized by FDA for Defective Insulin Pumps

Upon review of Medtronic’s facilities, the FDA found that the company lacked proper quality control.  The FDA initially discovered these shortcomings during an inspection in late 2008.  The violations included failing to maintain process control procedures to ensure products conformed to their specifications, failing to ensure accurate records for each batch, failing to evaluate and investigate consumer complaints, and failing to report problems where malfunctions could have resulted in serious injury or death.

The FDA also criticized Medtronic for taking two years to recall the insulin pump after the company discovered some models were missing a key propellant.  Medtronic initially identified problems in May 2006, but didn’t issue a recall or inform the FDA of the problem until May 2008.

Medtronic Insulin Pump Lawsuits

Medtronic Insulin Pump Lawsuits are currently being filed across the country.  If you have experienced a loss of consciousness, low or high blood sugar levels, or any other blood sugar related illness while using a Medtronic Insulin Pump you may be entitled to financial compensation. Contact one of our lawyers today for a free case consultation concerning any injuries related to a defective insulin pump. 

Published November 17, 2011 by