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Old 09-14-2017, 05:53 AM
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Default INSULIN PUMP RECALL

Medtronic plc (MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.

The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.

Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost.

Customer Instructions
Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change. Medtronic would like to remind customers that it is very important to carefully follow the Key Steps document included with the recall notification letter regarding the priming/fill-tubing process - especially if a person only has recalled infusion sets.

Customers in the United States (U.S.) can determine if they have recalled infusion sets by visiting https://checklots.medtronicdiabetes.com.

• See a copy of the U.S. recall notification letter here: www.medtronicdiabetes.com/notice7
• See priming/fill-tubing instructions here: www.medtronicdiabetes.com/priming
• See more information on infusion sets here: www.medtronicdiabetes.com/infusion-sets

Customers outside the U.S. will receive instructions specific to their country. In Europe, Middle East and Africa (EMEA region), customers can determine if they have recalled infusion sets by visiting www.mmc.medtronic-diabetes.com/look.

www.medtronic.com
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Old 09-15-2017, 01:55 PM
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Default Re: INSULIN PUMP RECALL

Got the notice in the mail today.

Along with a prepaid mailing label for the recall.

Important to note this is only for the infusion sets that connect the insulin pumps to the body, not for the actual insulin pumps.
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