Corporate News Blog – Medtronic Voluntarily Recalls Diabetes Infusion Sets Worldwide

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LONDON, UK / ACCESSWIRE / September 13, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Medtronic PLC (NYSE: MDT), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=MDT. The Company announced on September 11, 2017, that it is voluntarily recalling specific lots of infusion sets used with all models of Medtronic’s insulin pumps, due to the discontinuation of certain components in these infusion sets. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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The Company has contacted the US Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue.

Reason for Discontinuation of Infusion Sets

Medtronic’s investigations showed that a component, the vent membrane, in the recalled infusion sets is susceptible to being blocked by fluid during the process of priming/fill-tubing, leading to potential over-delivery of insulin, which may cause hypoglycemia and in extreme cases, death.

New infusion sets, that were made available to patients since April 2017, include a design update of this component which is believed to reduce the risk of insulin over-delivery after an infusion set change. Medtronic will ensure that recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost.

Medtronic Diabetes team to Quickly Complete all Exchanges

Francine Kaufman, M.D., Chief Medical Officer of the Diabetes Group at Medtronic, expressed that the Company’s priority is to work with patients to mitigate risks to patient safety. While Medtronic has shipped a significant number of the new and enhanced sets since April 2017, the Company is committed to replacing recalled infusion sets for all patients. She further added that the Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support its customers throughout this process.

Medtronic Established a Website to Determine if Patients have Recalled Infusion Sets

The Company instructs the patients to use infusion sets made with the new and enhanced component, the vent membrane. It has laid down Key Steps document included with the recall notification letter regarding the priming/fill-tubing process, especially for people with recalled infusion sets.

Medtronic has also established a website for customers to determine if they have recalled infusion sets. Patients can consult the advice of their healthcare professional regarding their medical treatment.

Impact on Investors

Most of the cost is likely to be incurred in Q2 and will depend on a variety of factors, including the amount of unused sets that patients ultimately return, which is difficult to predict.
The voluntary recall will not impact Diabetes Group’s revenue growth in Q2, or in the full fiscal year.
The cost is also not expected to impact earnings per share (EPS) guidance in Q2, or in the full fiscal year.

About Medtronic Plc.

Medtronic is the world’s largest standalone medical technology development Company, and is a global leader in medical technology, services and solutions, alleviating pain, restoring health, and extending life for millions of people around the world. Headquartered in Dublin, Ireland, the Company employs more than 84,000 people worldwide. Medtronic operational headquarters are in Fridley, Minnesota.

Last Close Stock Review

Medtronic’s share price finished yesterday’s trading session at $82.30, marginally up 0.91%. A total volume of 4.07 million shares have exchanged hands. The Company’s stock price surged 15.54% since the start of the year. Shares of the Company have a PE ratio of 27.60 and have a dividend yield of 2.24%. The stock currently has a market cap of $112.08 billion.

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