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
R1608995
Date
2016-10-07
Event Country
France
Event Source
ANSM
Event Source URL
https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/treillis-systeme-disque-obturateur-et-renfort-parietex-et-renfort-auto-grippant-en-polyester-progrip-medtronic-sofradim-production-rappel
Notes / Alerts

French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a lot withdrawal carried out by MEDTRONIC SOFRADIM Production. The affected users have received the attached mail (07/10/2016) (371 KB). This safety action is registered with the ANSM under the number R1608995.

Device

Parietex ™ Shutter and Reinforcement System with ProGrip ™ Polyester Reinforcement

Model / Serial
Product Description
medical_device
Manufacturer
MEDTRONIC SOFRADIM Production

Manufacturer

MEDTRONIC SOFRADIM Production

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
LAANSM

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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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 Parietex ™ Shutter and Reinforcement System with ProGrip ™ Polyester Reinforcement

What is this?

Device

Parietex ™ Shutter and Reinforcement System with ProGrip ™ Polyester Reinforcement

Manufacturer

MEDTRONIC SOFRADIM Production