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
2015-11-16
Event Country
Lebanon
Event Source
RLMPH
Event Source URL
https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202015/16-11-2015/InSync%C2%AEIIICardiacResynchronizationTherapyPacemakers.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

InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P) Models 8042, 8042B, 8042U

Model / Serial
Manufacturer
Medtronic

Manufacturer

Medtronic

Manufacturer Parent Company (2017)
Medtronic plc
Manufacturer comment
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Manufacturers representative
Tamer Frères S.A.L.
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 InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P) Models 8042, 8042B, 8042U

What is this?

Device

InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P) Models 8042, 8042B, 8042U

Manufacturer

Medtronic