The Recall Desk
ModerateFDA (Devices)·Z-2179-2014·Announced 2014-08-20

Medtronic MiniMed Guardian Monitor Recall for Water Resistance Issue

Medtronic MiniMed is recalling 86 Guardian REAL-Time monitors due to a manufacturing issue that may compromise water resistance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a manufacturing defect compromising water resistance without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medtronic MiniMed Inc. is recalling 86 units of the Guardian REAL-Time monitors, model numbers CSS7100 and CSS7100K. These devices are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The CSS7100 is the adult model, while the CSS7100K is the pediatric version.

The recall is being conducted because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors. The distribution of these units was worldwide, including the United States and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, and Switzerland.

Consumers should stop using the affected monitors and contact Medtronic MiniMed for further instructions. The information provided by these devices is intended to assist users in determining when an additional fingerstick glucose measurement may be appropriate, but all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters.

The recalled product

Product
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 subcuta
Manufacturer
Medtronic MiniMed Inc.
Category
Medical Device — Glucose Monitor
Hazard
Affected units
86

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • CSS7100 and CSS7100K

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Medtronic MiniMed Inc.

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