Agency classClass IIOur severity:High FDA (Devices)·Z-1767-2022·Announced 2022-09-28

Medical Device Recall: CARDIOHELP HLS Set Advanced Sterility Barrier Breach

Maquet Medical Systems is expanding its recall of the CARDIOHELP HLS Set Advanced due to a potential breach in the sterility barrier that could compromise product sterility, affecting 6,871 US units and 18,670 worldwide.

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 an FDA Class II recall without reported hospitalizations, illnesses, or injuries. The hazard is a potential sterility breach with theoretical contamination risk. No actual product failures or patient harm have been reported, placing this within the High severity category for risk-of-harm medical devices where injury has not yet been reported.

Plain-English summary

Maquet Medical Systems USA is expanding its recall of the BEQ-HLS 7050 USA (HLS Set Advanced 7.0, Part No. 70106.9078), a preconnected set used for extracorporeal respiratory and/or cardiovascular support as part of the CARDIOHELP System.

The recall was expanded due to a potential breach in the sterility barrier that may compromise product sterility. The original recall was initiated on November 6, 2020.

The expanded recall affects 6,871 units distributed in the United States and 18,670 units distributed worldwide, including Canada and Australia. Specific lot numbers are identified in the FDA recall documentation.

The recalled product

Product: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Manufacturer: Maquet Medical Systems USA
Category: Medical Device — Extracorporeal Support System
Hazard: sterility-breach
contamination

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)

UDI-DI: 04058863080383 Lots 3000190535
3000190536
3000190537
3000192076
3000192077
3000192078
3000192079
3000193358
3000193359
3000193360
3000193361
3000193362
3000195061
3000195062
3000195063
3000195064
3000195065
3000195066
3000195067
3000196193

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Maquet Medical Systems USA 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 4 products in this recall →

Same manufacturer · Maquet Medical Systems USA

See all →

High
CARDIOHELP-i System Recalled for Elevated Patient Leakage Current
FDA (Devices) · 2024-05-22
High
FDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect
FDA (Devices) · 2024-02-21
High
Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect
FDA (Devices) · 2024-02-21
High
RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk
FDA (Devices) · 2024-02-14
Moderate
Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label
FDA (Devices) · 2024-02-14

Same hazard · sterility breach