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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: CSS7100 and CSS7100K
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic MiniMed Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
CSS7100 and CSS7100K
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2179-2014
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