FDA Devices recall · Reported August 20, 2014
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for
Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian …
Medtronic MiniMed Inc. recalled Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Me… - a moderate-severity action.
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Me… was recalled by Medtronic MiniMed Inc. in August 20, 2014. Reason: Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the …. Check the official notice for the remedy. Verify recall #Z-2179-2014 with the FDA Devices before acting.
The recall
Medtronic MiniMed Inc. issued this moderate-severity FDA Devices recall-Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the ….
- Moderate
- severity level
- 86 units
- affected scope
- Class II
- classification
- August 20, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2179-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.
Reason for recall
Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2179-2014 |
| Date reported | August 20, 2014 |
| Date initiated | July 21, 2014 |
| Recalling firm | Medtronic MiniMed Inc. |
| Firm location | Northridge, CA |
| Affected scope | 86 units |
| Distribution | Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2179-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026