FDA Device recall Z-1612-2021
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 007630…
- FDA Device
- Class II
- ongoing
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 007630… by Medtronic, citing use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1612-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-26 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | n/a |
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.
Reason
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Identifiers
| code_info | All Lot numbers within active shelf life |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1612-2021%22
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