Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0.… recallZ-2149-2019 · Maquet Cardiovascular Us Sales, Llc · initiated Jul 11, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
FDA root cause category: Under Investigation by firm
What the company is doing
Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.
Recall details
- Recall number
- Z-2149-2019
- Status
- Terminated
- Initiated by the company
- Jul 11, 2019
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 54
- Product code
- DTZ
- FDA submissions
- K112360
- Distribution
- The products were distributed to the following US states: AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, and WI.
Product description
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Code information (models, lots, serial numbers)
Lot 70131093; UDI 04037691741543
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA HLS Set Advanced 7.0, Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
Other devices under the same FDA submission
3 devices cleared under K112360 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HLS Set BEQ-HLS 7050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls13 deaths90 reports
- HLS Set BEQ-HLS 5050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls4 reports
- NA HLS Set Advanced 5.0, Small Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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