Events

Field Safety Notices about All vascular prostheses brands Gelsoft, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS, Gelseal, Gelseal ERT Gelweave, K-Thin, K-Thin ERS, Gelseal Plus, Fluoropassiv, Fluoropassiv ER, Thin Wall Fluoropassiv, Thin Wall Fluoropassiv ER, SealPTFE and Taperflo and all cardiovascular patchgraft textile

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Vascutek 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 ID
6.6.4-2017-93589
Event Country
Sweden
Event Source
SMPA
Event Source URL
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Implantat--alla-vaskulara-proteser-och-kardiovaskulara-patchgraft-av-textil--Vascutek-LTD/#
Notes / Alerts

Swedish data is current through 2018. All of the data comes from the Swedish Medical Products 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 Sweden.
Extra notes in the data

SP17-001
Action
Modification of the manual.

Device

All vascular prostheses brands Gelsoft, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS, Gelseal, Gel...

Model / Serial
Implanted device?
Yes
Product Description
Implant
Manufacturer
Vascutek LTD

Manufacturer

Vascutek LTD

Manufacturer Parent Company (2017)
Terumo Corp.
Source
SMPA

About this database

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

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

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.

Download the data

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.

Download all (zipped)