U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Covidien received complaints of the sedecal generator failing and producing smoke at customer sites. the failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.
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Covidien Issued an "Urgent Device Correction" notification dated June 14, 2010 informing their customers of the potential problem. Consignees were instructed that Field Service Engineers will be in contact arrange a service visit to perform corrections on the affected units.
For further information, contact Covidien Product Monitoring at 1-800-778-7898.