Z-1005-2024Class II

Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2...

Name: Z-1005-2024 Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2...
Creator: Medtronic MiniMed, Inc.
Published: 2023-11-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-11-15 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic MiniMed, Inc. began a recall of 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 on 2023-11-15. FDA classified it as Class II and gives the reason as "Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1005-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-15
Posted: 2024-02-07
Recalling firm: Medtronic, Inc.
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
Product code: OZP Automated Insulin Dosing Device System, Single Hormonal Control
Reason for recall: Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On 11/15/23, recall notices were mailed or emailed to patients, distributors, and healthcare professionals who were told the following: 1) If you have affected devices discard and contact the firm to receive replacement sensors in the following ways: by completing the web form at medtronicdiabetes.com/G4S-form, contacting 24-Hour Technical Support at 800-646-4633, option 1, or email [email protected]. 2) If you cannot identify the LOT number of the sensor you are currently wearing, remove the sensor and replace your sensor with a non-impacted sensor. 3) Please complete and return the confirmation form via email to [email protected] Distributors were asked to either 1) notify impacted customers using the Correction Letter and provide status updates to the recalling firm regarding customer responses, or 2) provide the recalling firm with customer addresses so they can notify impacted customers. If you have any questions, please contact the firm at 800-646-4633, option 1.
Quantity in commerce: 114,758
Distribution: Worldwide - US Nationwide distribution including in the states of PR, AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Austria, Belgium, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Liechtenstein, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
Product codes and lots: 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, 00763000712471/F1323, F1923, G0323, G1723, G2023, G2623, G2923, HG6RV7S, HG6TGNU, HG6TJ2Y, HG6TW97, HG6TWVU, HG6UNF2, HG6V8NN, HG6VB8S, HG6VNX3, HG6WNE1, HG6XFPR, HG6XH54, HG6XQCG, HG6XZJX, HG6Y0W1, HG6Y3QN, HG6YEK6, HG6YFAF, HG6YFHL, HG6YJAR, HG6YJBD, HG6YNGD, HG6Z7N5, HG6ZARN, HG7038Y, HG70CW5, HG70DAM, HG70JSU, HG70LRC, HG70QWA, HG71VMZ, HG72DB5, HG72G9C, HG72NV9, HG72R1P, HG72RBD, HG72SE3, HG72TPT, HG72TRV, HG72V3J, HG72ZFP, HG7340A, HG73EJX, HG73RNR, HG745SV, HG747E3, HG7480Q, HG749N6, HG74F93, HG75TSX, HG75XA1, HG76HFH, HG76RYY; MMT-7040C2/20763000555287/HG6RC39, HG6RXB5, HG6T4T7, HG6T8RV, HG6TJ2Y, HG6WKZU, HG6WLKS, HG6XFPR, HG6XH54, HG6XLSD, HG6XNH3, HG6Y5C6, HG6Z1X5, HG713AK, HG73EGX, HG73EJX, HG73FJP, HG73Q24, HG73QPM, HG73RNR, HG7619X, HG764J9, HG76CWC, HG77FMK; MMT-7040C3/20763000555294/HG6XNH3, HG73RNR; MMT-7040D1/00763000413484/HG6THY1, HG6V7VV; MMT-7040D2/00763000413491/HG6TL44; MMT-7040MA/20763000519692/HG74460; MMT-7040QC1/00763000555313, 20763000555317/HG6WT9A, HG6WUGE, HG73PH3; MMT-7040QC2/20763000555324, 763000555320/HG6WT9A; MMT-7040QC3/20763000555331/HG6WT9A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1005-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1005-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-07

Product code OZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)