Medtronic Announces Worldwide Voluntary Recall for Battery Pack in Covidien Oridion Labeled Capnostream(TM)20 and Capnostream...
April 20 2016 - 8:00AM
DUBLIN - April 20, 2016 -
Medtronic is notifying customers worldwide of a voluntary recall
for the battery pack used in its Covidien Oridion labeled
Capnostream(TM)20 and Capnostream(TM)20p Patient Monitors. This
voluntary recall is being conducted due to a battery manufacturing
defect that may increase the risk of thermal damage in the battery
pack. The scope of this recall includes battery pack model numbers
016400 and 010520. These packs were manufactured by a contract
manufacturer between April 2014 and February 2016.
Capnostream monitors are external
(non-implantable) medical devices used to assess patients'
respiratory status and identify changes in breathing. The
prescription device is operated by trained healthcare professionals
in a clinical setting and in the home.
Medtronic has received seven reports of thermal
damage out of 9,817 battery packs impacted by this field action. Of
these seven reports, one involved a fire resulting in smoke
inhalation and minor burns.
On April 15, 2016, Medtronic sent a letter to
customers who have Capnostream battery packs affected by this
voluntary recall. The Company also supplied a rework kit with full
instructions for removal and proper disposal or recycling of the
battery pack according to local policy. The eight cell, 14.3 volt,
Lithium Ion battery pack is custom manufactured by third party
contract manufacturers.
The company recommends that customers use the
Capnostream monitors on AC power (with the battery pack removed)
until a replacement battery pack is available.
The company has identified a manufacturing change
conducted by the third party contract manufacturer as the probable
root cause and is manufacturing new batteries that meet original
specifications with a new contract manufacturer. The company will
supply new batteries to affected customers when available. No other
Medtronic products are affected by this supplier of battery
packs.
Medtronic has contacted the FDA and other
regulatory bodies to share information related to this issue. The
company will continue working directly with government authorities
and customers on this voluntary recall.
Adverse reactions or quality problems experienced
with the use of this product may be reported to the FDA's MedWatch
Adverse Event Reporting program online, by regular mail, or by
fax.
- Online: Complete and submit
the report to 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
or
- Email Medtronic Minimally
Invasive Therapies Group Post Market Vigilance at:
HQTSWEB@COVIDIEN.COM
- Call Medtronic Post Market
Vigilance at: +1-800-635-5267 option 1, option 1, and again
option 1.
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 85,000 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:
John Jordan
Public Relations
+1-508-452-4891
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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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