International Medical Devices Database

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

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Type of Event
Recall
Date
2017-06-28
Event Country
Lebanon
Event Source
RLMPH
Event Source URL
https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202017/28-6-2017/HeartMate3LeftVentricularAssistsystem(LVAS).pdf
Notes / Alerts

Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
Extra notes in the data

Device

HeartMate 3 Left Ventricular Assist System (LVAS)

Model / Serial
Product Classification
Cardiovascular Devices
Manufacturer
St Jude Medical

Manufacturer

St Jude Medical

Manufacturer Parent Company (2017)
Abbott Laboratories
Manufacturer comment
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
Manufacturers representative
Basic Trading Company
Source
RLMPH

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Disclaimer

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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Recall of HeartMate 3 Left Ventricular Assist System (LVAS)

What is this?

Device

HeartMate 3 Left Ventricular Assist System (LVAS)

Manufacturer

St Jude Medical