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FDA issues Class I recall for defective insulin pumps

Ohio residents who live with Type 1 diabetes may discover their lives are in jeopardy. Medtronic manufactures an insulin pump called the MiniMed that comes in two versions -- one for people age 16 and up and one for children ages 7 and up. The Food and Drug Administration recently issued a Class I recall for certain lots of the MiniMed due to a problem with a missing or broken retainer ring.

Without this retainer ring, the insulin cartridge may not lock into the pump's reservoir compartment. As a result, the device may deliver too much or too little insulin, which is why the FDA calls this a Class I recall, which is the agency's most serious recall, since using the defective product may cause serious injuries or death in unsuspecting patients who rely on the device. So far, Medtronic has received approximately 26,421 complaints about the device, reports of one death and reports of 2,175 injuries.

Back in Nov. 2019, Medtronic issued an advisory to customers who use the affected devices to inspect the retainer ring and make sure the insulin cartridge will lock into place before using the insulin pump. If a patient finds a problem with his or her device, its use should be stopped immediately. It will be necessary to talk to a doctor immediately as well in order to get a replacement pump as quickly as possible.

This particular device has already claimed at least one life and caused thousands of injuries, which is part of the reason why the FDA has designated this recall as a Class I recall. Anyone here in Ohio who discovers that he or she suffered injuries or lost a loved one to a defective insulin pump may want to explore the legal options available. A thorough review of the circumstances could reveal that litigation is the best way forward.

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