Class II — Maquet Cardiovascular Us Sales, Llc
| Recalling firm | Maquet Cardiovascular LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794 |
| Quantity | 54 |
| 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. |
| Initiated | 2019-07-11 |
| Classified | 2019-09-13 |
| Terminated | 2020-12-11 |
| Recall number | Z-2149-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Cardiovascular Us Sales, Llc (Z-2149-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83336/
Alerts for Maquet Cardiovascular LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.