Medtronic Recalls Insulin Pumps After More Than 2,000 Injuries, One Death

Regulatory NewsRegulatory News
| 12 February 2020 | By Zachary Brennan 

A larger version of this photo can be seen in Medtronic's letter.

The US Food and Drug Administration (FDA) on Wednesday announced that Minnesota-based device manufacturer Medtronic is recalling certain insulin pumps that might not provide the correct insulin dosing.

The Class I recall, the most serious type of recall, was first announced by Medtronic last November for 322,005 of its US-distributed MiniMed 600 Series Insulin Pumps (481,875 of the devices were distributed worldwide). The recall concerns two types of models (630G and 670G) distributed between September 2016 and August 2019.

In 2018, the 670G model’s approval, initially for patients 14 years of age and older with type 1 diabetes, was expanded by FDA to include individuals aged 7 to 13 with type 1 diabetes.

Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment.

“If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death,” FDA said.

Medtronic said it received 26,421 complaints in which the device malfunctioned in this way, and the firm is aware of 2,175 injuries and one death.

“Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your doctor's recommendations and perform manual insulin injections,” Medtronic advised customers. “Continue using the pump if the reservoir locks in place correctly. If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.”

Class I Recall

Medtronic Letter


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