Massive Recall of Insulin Pumps after 26,000 Complaints
Medtronic has issued a recall of more 300,000 insulin pumps due to a risk of over-delivery or under-delivery of insulin which can lead to serious injury or even death. According to the FDA, the pumps are being recalled due to a “missing or broken retainer ring” which could lead to the failure to firmly lock the insulin cartridge in place potentially causing an over- or under-delivery. The pump models are the 630G and 670G marketed by Medtronic as its “artificial pancreas” because it is a closed-loop system which automates blood glucose monitoring and insulin delivery. The affected lots are those manufactured before October 2019 and distributed between September 2016 and October 2019 (630G model) or manufactured before August 2019 and distributed between June 2017 and August 2019 (670G model). The FDA noted that Medtronic had received a total of more than 26,400 complaints of which 2,175 reported injury with 1 known death. The FDA has characterized the recall as a Class I recall, the most serious type of recall because use of the devices could lead to serious injuries or death.
You can read the FDA statement in full here.
The lawyers at Williams Cedar have substantial experience with Medtronic medical devices including and especially its insulin pumps. If you or a loved one suffered an injury while using one of these recalled pump models, call us for a free consultation at 215-557-0099 or submit the online inquiry form below.