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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 37200 E-Circuit Bioline Heparin Material: 701055388R01
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 Universal Pk Material: 701054874R01
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 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
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 Pack Material:701054438R01
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 27700 Quadrox iD Pack Material: 701054389R02
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 24202 ADULT ECC Material: 701054295R01
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: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-
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 250011/4 1/4 Less than 20 kg up Material: 701053906R01
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 20705 SMALL PATIENT 1/4 Material: 701053486R01
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 32200 ECC Pack Material: 701053319R01
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 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01
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 28601 NEONATE ECC QPiD Material: 701051935R01
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 5502 ECC Pack Material:701051791R01
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 15704 Circulatory Circuit 3/8" Material:701050859R01
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 15200 OR PACK HMO & RF Material:701050647R01
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 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01
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 24101 Adult ECC Pack Material:701050177R01
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 24100 Small Patient ECC Pack Material:701050175R02
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 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01
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 22600 ECC QUADROX iD 3/8 Material:701049440R02
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 22600 ECC QUADROX ID 3 Material:701049440R01
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 17207 3/8" ECC Pack Material:701049346R01
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 5103 CPS Tubing Pack Material:701048690R01
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 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
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 4932 Mercy Adaptation Pk Pediatric Material:709000520
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 31604 CHKD 1/4" ECC Material: 709000518
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 31603 CHKD 3/8" ECC Material: 709000516
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 48003 Rotaflow ONLY Support Pack Material:709000490
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 25503 TMC ¿ with BB & QiD Pedi Material:709000473
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 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460
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