FDA Updates Labeling for LIPOSORBER LDL Adsorption Column Due to Anaphylactoid Shock Risk
LIPOSORBER LA-15 LDL Adsorption Column labeling has been updated to address a risk of severe anaphylactoid reactions and shock in patients receiving treatment while taking ACE inhibitors.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a serious documented risk of anaphylactoid reactions and shock in patients on ACE inhibitors. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product without reported injury receives a High (3) severity score.
Plain-English summary
The FDA has issued a labeling update for the LIPOSORBER System Model LA-15, an LDL Adsorption Column manufactured by Kaneka America Corp. The device is used for plasma treatment to reduce high cholesterol. The updated labeling reflects a documented risk of severe anaphylactoid reactions, including shock, in patients who are taking ACE inhibitor medications while undergoing treatment with this device.
Kaneka America Corp distributed 138 LIPOSORBER systems and 54,703 associated disposables across 34 U.S. states. All product lots and UDI numbers are subject to this labeling change.
The recalled product
- Product
- LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column…
- Manufacturer
- Kaneka America Corp
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 (1)
- All product lot and UDI numbers are affected.
Distribution
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