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
Event ID
19518
Event Risk Class
I
Event Initiated Date
2011-11-17
Event Country
Canada
Event Source
HC
Notes / Alerts

Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Extra notes in the data
Reason
The radiopaque segment may detach during in vivo use resulting in device fragments that will remain in the patient's vasculature.

Device

H.LEE SAFESHEATH LVI (LATERAL VEIN INTRODUCER) SHEATH

Model / Serial
Model Catalog: LVI/75-5-62-07-RE (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/TELE/B-60-07-MP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/TELE/B-60-07-RE (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/75-5-62-07-HS (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/75-5-62-07-MP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/TELE/B-60-07-HO (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/BCOR-2-09 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/L/BCOR-1-09 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/BCOR-1-09 (Lot serial: >10 NUMBERS CONTACT MFR)
Product Classification
Cardiovascular Devices
Product Description
SAFESHEATH LATERAL VEIN INTRODUCER
Manufacturer
MERIT MEDICAL SYSTEMS INC.

Manufacturer

MERIT MEDICAL SYSTEMS INC.

Manufacturer Address
MALVERN
Manufacturer Parent Company (2017)
Merit Medical Systems Inc
Source
HC

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 H.LEE SAFESHEATH LVI (LATERAL VEIN INTRODUCER) SHEATH

What is this?

Device

H.LEE SAFESHEATH LVI (LATERAL VEIN INTRODUCER) SHEATH

Manufacturer

MERIT MEDICAL SYSTEMS INC.