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Getinge / Maquet Cardiopulmonary GmbH Amends Medical Device Removal for Additional Lots of ROTAFLOW Centrifugal Pumps (RF-32 Pumps)

On January 8, 2024, Getinge / Maquet Cardiopulmonary GmbH (MCP) notified affected customers of a nationwide recall (medical device removal) for certain lots of ROTAFLOW Centrifugal Pumps (RF-32 pumps) due to a potentially compromised sterile barrier.  The RF-32 pumps are intended to maintain blood flow during extracorporeal circulation and are packaged in sterile bags supplied to MCP/Getinge from its supplier, Nelipak.

On March 20, 2024, Getinge / Maquet Cardiopulmonary GmbH (MCP) notified affected customers of additional lot numbers affected by the above recall.

Please download the notice for more comprehensive information and instructions.

Medical Device Removal for Certain Lots of RF-32 ROTAFLOW Centrifugal Pumps Download PDF

Medical Device Removal Notice - Quadrox

Maquet Cardiopulmonary GmbH/Getinge is initiating a voluntary Medical Device Removal for the Cardiotomy Reservoirs (VKMO 10000-USA, VKMO 11000-USA), QUADROX-iD (BEQ-HMOD 30000, HMOD 70000, and BEQ-HMOD 70000), QUADROX-iR (HMO 71100, HMO 70100, BEQ-HMO 71100, HMO 51100, HMO 50100, BEQ-HMO 51100), and QUADROX-, i (HMO 50000, HMO 51000, HMO 70000, HMO 71000, and BEQ_HMO 71000, HMO 10000, HMO 11000, HMO 30000 and HMO 31000) Oxygenators due to a risk of potentially compromised packaging sterility that may result in the risk of infection/harm to the patient. All lots are being removed. 

Please download the notice for more comprehensive information and instructions.

Quadrox Oxygenator Notice 18 May 2023 Download PDF