Z-1612-2021Class II

Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084...

Name: Z-1612-2021 Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084...
Creator: Medtronic Inc.
Published: 2021-02-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-02-26 / Open, Classified

FDA source

Medtronic Inc. began a recall of Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L... on 2021-02-26. FDA classified it as Class II and gives the reason as "Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1612-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-26
Posted: 2021-05-17
Recalling firm: Medtronic, Inc.
Product: Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Product code: MDS Sensor, Glucose, Invasive
Reason for recall: Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
FDA root cause: Under Investigation by firm
Action: On February 26, 2021, Medtronic posted the "Urgent Recall Correction" notification to their website. On March 2, 2201, Medtronic provided U.S HCPs, Patients, Distributors and globally affected Clinical trial sites with a copy of the "Urgent Recall Correction" Notification. On March 8, 2021, Medtronic provided OUS patients, HCP and distributions with a copy of the "Urgent Recall Correction" notification Communication was provided to users via: email, fax, and/or mail. In addition to informing affected users about the correction, Medtronic ask consignees to take the following actions: Do not use continuous glucose monitoring (CGM) while taking hydroxyurea. Only use their BG meter to monitor glucose levels while taking hydroxyurea. Consult with the HCP if they are taking hydroxyurea and using a CGM. When using an insulin pump system, they should disable the CGM feature by going to the sensor settings and refer to the user guide that came with the insulin pump for instructions. Always check the label of any medication and confirm with you whether or not hydroxyurea or hydroxycarbamide is an active ingredient. If further distributed, please provide those consignees with a copy of the notification. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Complete and submit the report Online: www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Quantity in commerce: 111,678 units
Distribution: Worldwide distribution.
Product codes and lots: All Lot numbers within active shelf life

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1612-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1599-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1600-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1601-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1602-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1603-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1604-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1605-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1606-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1607-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1608-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1609-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1610-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1611-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1612-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1613-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1614-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1615-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1616-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1617-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17
Z-1618-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-17

Product code MDS

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)