Elana Surgical KitHUD Recalled Due to Compromised Sterile Packaging Integrity
Elana, Inc. is voluntarily removing four Elana Surgical KitHUD units because the sterile packaging of the included catheter may be compromised.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall (Field Action) regarding packaging integrity. The source text does not report any illnesses, injuries, or deaths, and the hazard is theoretical (potential loss of sterility), fitting the criteria for a moderate severity score.
Plain-English summary
Elana, Inc. has issued a Field Action to voluntarily remove specific serial numbers of the Elana Surgical KitHUD. The recall is due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0, which is part of the kit.
The Elana Surgical KitHUD 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 intracranial artery. The device is used in conjunction with the Spectranetics Xenon-Chloride Laser Model CVX-300.
The affected units are identified by Manufacturer's Product Number 801-H and Lot/Serial Number 160301. A total of four units were distributed worldwide, including the United States (specifically New York), Switzerland, and the Netherlands. Healthcare providers and patients should stop using the affected units and contact Elana, Inc. for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Elana, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Manufacturers Product Number
- 801-H Lot/Serial Number
- 160301
Distribution
Distributed in 1 state:
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