FDA (Devices) recall action 90370
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.
MiniMed 670G Insulin Pump may lose power due to battery cap deterioration, affecting approximately 279,251 units distributed in the U.S. and overseas.
Medtronic MiniMed is recalling 83,398 MiniMed 780G insulin pumps distributed throughout the United States due to battery cap deterioration that may cause power loss and device malfunction.
Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.
Medtronic has recalled approximately 323,417 MiniMed 640G insulin pumps due to battery cap deterioration that may cause loss of power and functionality. Patients should contact Medtronic or their healthcare provider immediately.
Medtronic recalls certain MiniMed 740G Insulin Pumps due to battery cap deterioration that may cause loss of power and functionality. No illnesses have been reported.
Medtronic MiniMed is recalling approximately 575 MiniMed 720G Insulin Pumps due to battery cap deterioration that may result in power loss and device malfunction.
Medtronic is recalling MiniMed 770G insulin pumps because battery cap deterioration may cause power loss and insulin delivery failure. Approximately 123,585 units are affected.