MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramDiabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by FluidAUDIENCE: Patient, Nursing, Risk Manager ISSUE: Medtronic is informing 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. See the press release for affected lots and patient information. BACKGROUND: 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. RECOMMENDATION: 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. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch Safety Alert, including links to the press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm575778 You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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