FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall
April 18 2017 - 4:31PM
DUBLIN - April 18, 2017 -
Medtronic plc (NYSE: MDT) announced today that the U.S. Food and
Drug Administration (FDA) has classified the company's recently
initiated voluntary field action related to its HVAD(TM) System
Controllers (serial numbers lower than CON300000) and DC Adapters
(all serial numbers for product code 1435) as a Class I recall.
Medtronic began notifying clinicians outside of
the United States in March 2017 about updated HVAD System
Controllers and DC Adapters that were developed following two
previously communicated Field Safety Notices that occurred in April
2015 and April 2016. The FDA approved the updated controller on
April 7, 2017, and Medtronic began notifying U.S. clinicians about
the updated HVAD Controllers and DC Adapters on April 14, 2017.
The updated controller includes enhancements
designed to address the potential safety issues identified in the
previously communicated notices, including:
-
strengthened power and serial port alignment
guides intended to reduce the incidence of wear that could lead to
damaged connector pins;
-
functionality designed to monitor internal
battery performance and sound an alert when the internal battery is
nearing depletion; and
-
redesigned connectors and housing intended to
prevent the risk of connectors loosening or becoming more
vulnerable to damage from exposure to water and other fluids.
In addition, the updated controller introduces
upgraded internal circuitry designed to improve overall device
reliability.
In April 2015 and April 2016, Medtronic notified
clinicians about potential safety issues with the current HVAD
System Controller that could lead to possible injury and death due
to worn alignment guides, internal "double disconnect (no power)
alarm" battery failure, and loose power and data connectors.
With the introduction of the updated controller,
Medtronic has begun to remove current HVAD Controllers (product
codes 1400,1401US and 1407US) in select geographies, including the
U.S. Medtronic also has begun to remove the related adapters
(product code 1435), Instructions for Use, Patient Manuals and
Emergency Responder Guides.
As part of these activities, Medtronic has
provided the following recommendations to physicians:
-
Before the updated controller will be
distributed to hospitals, clinicians must complete required
training on the updated controller and updated product labeling,
including the Instructions for Use and Patient Manual.
-
Following training and the receipt of the
updated controllers in hospital inventory, clinicians are requested
to quarantine and replace patients' primary and backup HVAD
Controllers and DC adapters under clinical supervision and at a
hospital where patient support equipment is available.
-
While Medtronic recommends that HVAD Controllers
be exchanged, clinicians should weigh the benefits of the updated
controller against the risks of a controller exchange
procedure.
-
When clinicians determine a controller exchange
is appropriate, they will notify patients who should promptly
schedule a controller exchange as soon as the updated controllers
are available.
-
Trained hospital staff must educate patients on
using the updated controller.
Patients with questions about this announcement
should contact their physicians or ventricular assist device (VAD)
coordinator at their hospital center.
Adverse reactions or quality problems experienced
with the use of this device may be reported to the FDA's MedWatch
Adverse Event Reporting program either online, by regular mail or
by fax:
-
Complete and submit the report
online: www.fda.gov/medwatch/report.htm
-
Regular mail or fax: Download
form www.fda.gov/MedWatch/getforms.htm or call
+1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax
to +1-800-FDA-0178
For information or to report a problem, please
contact the 24-hour Clinical Support line at +1-888-494-6365 or
email FSCA@medtronic.com.
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 88,000 people worldwide, serving physicians,
hospitals and patients in more than 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:
Kathleen Janasz
Public Relations
+1-763-526-3676
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
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