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.

Learn more about the data here

Type of Event
Recall
Event ID
1762475
Event Date Posted
2016-10-24
Event Country
Greece
Event Source
NOM
Event Source URL
http://www.eof.gr/web/guest/withdrawalsmedical?p_p_id=62_INSTANCE_Eh5C&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&_62_INSTANCE_Eh5C_struts_action=%2Fjournal_articles%2Fview&_62_INSTANCE_Eh5C_groupId=12225&_62_INSTANCE_Eh5C_articleId=1762475&_62_INSTANCE_Eh5C_version=1.0
Notes / Alerts

Greek data is current through July 2018. All of the data comes from the National Organization for Medicines, 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 Greece.
Extra notes in the data
Action
Recall of Pipeline Embolization Device (Pipeline classic), Alligator Retrieval Device, Marathon Flow Directed Microcatheter, UltraFlow HPC Flow Directed Microcatheter and Xcelerator Hydrophilic Guidewire

Device

Pipeline Embolization (Pipeline classic), Alligator Retrieval , Marathon Flow Directed Microcath...

Model / Serial
Product Classification
Cardiovascular Devices
Product Description
Recovery of the Pipeline Embolization Device (Pipeline classic), Alligator Retrieval Device, Marathon Flow Directed Microcatheter (with Sword), UltraFlow HPC Flow Directed Microcatheter (with Stylix) and Xcelerator Hydrophilic Guidewire
Manufacturer
Micro Therapeutics, Inc., USA

Manufacturer

Micro Therapeutics, Inc., USA

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.
Source
NOM

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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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Recall of Pipeline Embolization (Pipeline classic), Alligator Retrieval , Marathon Flow Directed Microcatheter (with Sword), UltraFlow HPC Flow Directed Microcatheter (with Stylix) and Xcelerator Hydrophilic Guidewire

What is this?

Device

Pipeline Embolization (Pipeline classic), Alligator Retrieval , Marathon Flow Directed Microcath...

Manufacturer

Micro Therapeutics, Inc., USA