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Maquet Cardiovascular Recalls
252 recalls on record · January 16, 2013 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured