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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-TOP 8207 1/4" ECC PACK Material: 701068395
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 3502 LVAD 1/4" Material: 701068168
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 3501 LVAD/ 3/8" Material: 701068008
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 50100 CHOSA 1/4" ECC PACK Material: 701067837
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 35503 SGD PACK Material: 701067668
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 37305 1/4+3/8 TABLE LINE Material: 701067577
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 14605 OPEN HEART WITHOU Material: 701067372
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 5208 ECC SET CARDIAC Material: 701067350
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 49002 ROTAFLOW SUPPORT PACK Material: 701067280
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 4963 CARDIOPLEGIA PACK Material: 701067203
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 8068 1/4" WITH BRIDGE Material: 701066883
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 4903 Mercy Med w/o Oxy Material:701066664
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 47800 STRINGFELLOW PED Material:701066583
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 41303 AV MANIFOLD FOR ECC PA Material:701066551
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 9405 LARGE PATIENT TBG P Material:701066366
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-T 41302 PRIMING LINES BUMC Material:701066291
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 16405 LIVER TX INFUSION Material:701066097
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 46500 PRIME PACK Material:701065823
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 30907 ECC PUMP PACK Material: 701065770
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 36504 ADULT ECC PACK Material: 701065765
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-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
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 31204 CUSTOM PACK PEDI Material: 701065512
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 31203 CUSTOM PACK NEO Material: 701065510
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 27609 ECC PACK 1/4" Material: 701065504
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-T 41301 BUMC ECC PACK Material: 701065209
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 37302 Quadrox iD Pediatric Pack Material: 701065190
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 5909 1/4 PACK W QPID Material: 701064992
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 8069 Pediatric Pack Material: 701064965
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 41201 ECC 3/8 PUMP PAC Material: 701064867
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-T 44201 MAYO PULMONARY PACK Material: 701064834
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