CLASS II ONGOING Device recall · Reported 26 May 2021 · FDA Enforcement Report
Medtronic REF: Mmt-7020C4 Guardian Sensor (3) for the following recalled
Medtronic is recalling Medtronic REF: Mmt-7020C4 Guardian Sensor (3) for the following. The recall was initiated on 26 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1610-2021
- FDA event ID
- 87476
- Recalling firm
- Medtronic, Northridge, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Feb 2021
- FDA classified
- 17 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 26 Feb 2021 | Recall initiated by company | |
| 17 May 2021 | Classified by FDA | +80 days |
| 26 May 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Medtronic REF: Mmt-7020C4 Guardian Sensor (3) for the following recalled?
Yes. Medtronic recalled Medtronic REF: Mmt-7020C4 Guardian Sensor (3) for the following on 26 Feb 2021. The recall is Class II and its status is Ongoing. Recall number Z-1610-2021.
Why was it recalled?
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Which lots are affected?
All Lot numbers within active shelf life
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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