Events

Field Safety Notices about carpentier-edwards porcine valve model 2625, sav porcine valve model 2650 and 6650, carpentier-edwards perimount model 2900, 6900p and 6900ptfx, carpentier-edwards perimount magna model 3000 and 3000tfx, carpentier-edwards perimount magna ease model 3300tfx, carpentier-edwards perimount magna mitral model 7000tfx, carpentier-edwards perimount magna mitral ease model 7300tfx

According to Danish Medicines Agency, this field safety notices involved a device in Denmark that was produced by Edwards Lifesciences Ltd..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here

Type of Event
Field Safety Notice
Event Number
LMST-2012052722
Date
2012-05-28
Event Country
Denmark
Event Source
DMA
Event Source URL
https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/carpentier-edwards-porcine-valve-og-carpentier-edwards-perimount-forskellige-produkter-og-modeller/
Notes / Alerts

Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
Extra notes in the data

Device

carpentier-edwards porcine valve model 2625, sav porcine valve model 2650 and 6650, carpentier-ed...

Model / Serial
Manufacturer
Edwards Lifesciences Ltd.

Manufacturer

Edwards Lifesciences Ltd.

Manufacturer Parent Company (2017)
Edwards Lifesciences Corporation
Source
DMA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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