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
Date
2015-08-25
Event Country
Lebanon
Event Source
RLMPH
Event Source URL
https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202015/25-8-2015/Spiroflex%C2%AEAngioJet%C2%AEThrombectomySet.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

Spiroflex® AngioJet® Thrombectomy Set AngioJet® SOLENT™ omni

Model / Serial
Manufacturer
Boston Scientific International S.A.

Manufacturer

Boston Scientific International S.A.

Manufacturer Parent Company (2017)
Boston Scientific
Manufacturer comment
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
Manufacturers representative
Medilife s.a.l.
Source
RLMPH

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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 Spiroflex® AngioJet® Thrombectomy Set AngioJet® SOLENT™ omni

What is this?

Device

Spiroflex® AngioJet® Thrombectomy Set AngioJet® SOLENT™ omni

Manufacturer

Boston Scientific International S.A.