FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 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.
- Recall number
- Z-1610-2021
- Recalling firm
- Medtronic Inc.
- Product
- Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 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.
- Status
- Open, Classified
- Initiated
- 2021-02-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 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
- 54,211 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- All Lot numbers within active shelf life
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDS
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28