FDAMarch 11, 2016device
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
What to do
FDA enforcement status: Terminated
Brands named
datascope
UPCs
10607567203300
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABattery Charging Station; Model: 0998-00-0802;2026-02-06
- FDACS100 IABP. Software Version CS100 IABP Q.01.2026-01-23
- FDACS300 IABP. Software Version CS300 IABP C.01.2026-01-23
- FDACardiosave Rescue. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid2025-10-23
- FDACardiosave Rescue2025-10-23
- FDAMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-012024-09-17
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