Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches
Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.
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: The recall is classified as FDA Class II. The hazard involves a breach in the sterility barrier of a device used for extracorporeal circulation, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the HLS Set Advanced (disposable for Cardiohelp) because of breaches in the product's sterility barrier. These devices are used with the CARDIOHELP system to provide extracorporeal circulation for cardiac support and/or pulmonary support.
The recall affects 58,438 devices worldwide, including distribution across the United States and numerous international markets. The specific model is BEQ-HLS 5050 USA (HLS Set Advanced 5.0) with product code 70105.2797.
Healthcare facilities and users should stop using the affected devices and contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Category
- Medical Device — Cardiac Support
- Affected units
- 58,438
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 (20)
- 70127791
- 70127792
- 70127793
- 70127921
- 70127922
- 70127923
- 70127924
- 70128195
- 70128196
- 70128197
- 70128328
- 70128329
- 70128330
- 70128331
- 70129242
- 70129243
- 70129244
- 70129245
- 70129380
- 70129381
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Maquet Cardiovascular Us Sales, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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