Recall Z-2179-2014— Medtronic MiniMed Inc.

Class II FDA medical device recall by Medtronic MiniMed Inc., initiated 2014-07-21, terminated 2014-10-08. FDA's recall record names no specific 510(k) clearance for this event. 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 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: 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..

Recalling firm

Medtronic MiniMed Inc.

Classification

Class II

Status

Terminated

Initiated

2014-07-21

Terminated

2014-10-08

Firm location

Northridge, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.