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Medtronic MiniMed Guardian Monitor, Model No. CSS7100… recallZ-2179-2014 · Medtronic MiniMed Inc. · initiated Jul 21, 2014

Class II Terminated All recalls posted in August 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic MiniMed Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

Medical Device Recall letters dated July 21, 2014 andJuly 22, 2014 were sent to distributors, patients, and healthcare providers who purchased the Guardian REAL time monitors. The letters inform the customers of the problems identified and the actions to be taken. Distributors with questions are instructed to email [email protected]. If healthcare professionals want to speak to Medtronic's medical officers then they are instructed to call (818) 576-4211, ext. 64511. Customers and healthcare professionals' patients are instructed to call Guardian Recall Hotline at (800) 646-4633, ext. 21090, 8am-6pm, CST.

Recall details

Recall number
Z-2179-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 21, 2014
Posted by the FDA
Aug 10, 2014
Recalling firm
Medtronic MiniMed Inc.
Quantity
86 units
Product code
MDS
FDA submissions
P980022
Distribution
Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.

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.

Code information (models, lots, serial numbers)

CSS7100 and CSS7100K

Other devices under the same FDA submission

277 devices cleared under P980022 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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