Medical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect
Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a risk-of-harm medical device (continuous glucose monitor). No hospitalizations or injuries reported, but the identified manufacturing defect creates genuine risk for serious medical consequences: sensor malfunction could lead to inaccurate glucose readings and improper insulin dosing, potentially causing hyperglycemia or hypoglycemia. Meets the rubric criterion for High severity.
Plain-English summary
Medtronic MiniMed, Inc. is recalling Guardian 4 Glucose Sensors due to a manufacturing defect affecting the glucose oxidase (GOX) layer. The GOX layer thickness in some affected sensors falls outside the specification range of 5.5 to 9.2 micrometers.
The affected sensors include reference numbers MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, and MMT-7040QC3, with specific lot codes identified by Medtronic. Approximately 114,758 units are affected, distributed worldwide including throughout the United States and multiple international countries.
When the GOX layer is too thin, it can impair sensor function or result in complete loss of function. This may cause the sensor to provide inaccurate glucose readings. If glucose readings are affected, users may receive incorrect insulin dosing recommendations, potentially resulting in too little insulin (hyperglycemia) or too much insulin (hypoglycemia). The impact ranges from user inconvenience to serious medical consequences depending on the extent of malfunction.
Patients using Guardian 4 Glucose Sensors should check their device reference number and lot code against the recall notification. Individuals with affected devices should contact their healthcare provider or Medtronic for guidance on device replacement or continued use.
The recalled product
- Product
- Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
- Manufacturer
- Medtronic MiniMed, Inc.
- Affected units
- 114,758
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lot: MMT-7040A/20763000413389/HG72B2C
- HG72CQQ
- HG73VB7
- HG73VC8
- HG73VFT
- HG73WFR
- HG7441E
- HG745F9
- HG7486X
- HG74AJ1
- HG74SUR
- HG74T9Q
- HG74U36
- HG78LMS
- HG79Y9U
- MMT-7040C1/00763000555276
- 00763000413392
- 20763000413396
- 20763000555270
- 20763000712475
Distribution
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