Medtronic Announces Voluntary Recall of Diabetes Infusion Sets
(Thomson Reuters ONE) -
DUBLIN - September 11, 2017 - Medtronic plc (NYSE: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.
Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with
other regulatory bodies around the world, to share information related to this
issue. Medtronic will continue working directly with government and regulatory
authorities on this global voluntary recall.
"Our priority is to work with our patients to mitigate risk to patient safety.
While we have shipped a significant number of the new and enhanced sets since
April, we are committed to replacing recalled infusion sets for all patients,"
said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at
Medtronic. "Our Medtronic Diabetes team will work as quickly as possible to
complete all exchanges to the new and enhanced set and fully support our
customers throughout this process."
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.
Patients can always consult the advice of their healthcare professional
regarding their medical treatment.
If a customer in the U.S. has experienced an issue with the use of a Medtronic
infusion set, please report it to the 24-hour helpline at +1-800-204-7616.
Customers can also report adverse events to the FDA's MedWatch Adverse Event
Reporting program:
* Online at: http://www.fda.gov/safety/medwatch/howtoreport/default.htm
* Report by telephone: +1-800-FDA-1088
* Fax report: +1-800-FDA-0178
Investor Information
The voluntary recall of infusion sets is not expected to impact Diabetes Group
revenue growth in the second quarter or the full fiscal year. The majority of
the cost is expected to be incurred in the second quarter, and will depend on a
variety of factors, including the amount of unused sets that patients ultimately
return, which is difficult to predict. At this point, the cost is not expected
to impact earnings per share (EPS) guidance in the second quarter or full fiscal
year.
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change the way people
manage diabetes. The company aims to transform diabetes care by expanding
access, integrating care and improving outcomes, so people living with diabetes
can enjoy greater freedom and better health.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among
the world's largest medical technology, services and solutions companies -
alleviating pain, restoring health and extending life for millions of people
around the world. Medtronic employs more than 84,000 people worldwide, serving
physicians, hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
results.
-end-
Contacts:
Pamela Reese
Public Relations
+1-818-576-3398
Fernando Vivanco
Public Relations
+1-763-505-3780
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 11.09.2017 - 12:45 Uhr
Sprache: Deutsch
News-ID 559425
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contact information:
Town:
Dublin
Kategorie:
Business News
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