Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

FDA Recall Z-0698-2017 · Posted None

Recalling FirmElana, Inc.
Recall StatusTerminated
Product CodePAX
Date Initiated2016-11-09
Date Terminated2016-12-20
Product Quantity4

Reason for Recall

Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0.

Firm Action

Elana sent an Urgent Medical Device Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected device and to return the product for replacement. Customers were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return and exchange. Customers with questions were instructed to call 301-215-7010.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑