Guardian 4 Sensor
Medtronic MiniMed, Inc. · Continuous glucose monitors
No linked recall recordsLatest source check Oct 8, 2026
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Devices and FDA recall records listed on MedWatcher for Medtronic MiniMed, Inc..
This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.
Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.
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Medtronic MiniMed, Inc. · Continuous glucose monitors
No linked recall recordsLatest source check Oct 8, 2026
Medtronic MiniMed, Inc. · Continuous glucose monitors
No linked recall recordsLatest source check Oct 8, 2026
Medtronic MiniMed, Inc. · Insulin pumps
No linked recall recordsLatest source check Aug 17, 2026
Medtronic MiniMed, Inc. · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users…
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic…
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23.…
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in…
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected…
Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low…