Press release, July 18, 2019, Gothenburg, Sweden
Getinge informs about a global Class 1 recall for Cardiosave IABP and CS100/300
Getinge is informing about a global Class 1 recall for Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100 Intra-Aortic Balloon Pumps (IABP). This field correction is being conducted to ensure all IABP users follow each device's Operating Instructions Manual for recommendations on usage, charging, maintenance and storage of the batteries, as battery run times and discharge cycles vary between IABP models. Getinge has reported to relevant authorities according to applicable regulations and the cost for the recall is not material.
The reason for the recall is to help Getinge’s customers avoid battery shut down by ensuring all IABP users follow each device's Operating Instructions Manual for recommendations on usage, charging, maintenance and storage of the batteries.
Each consignee was contacted regarding availability of a recently developed battery operations, care and maintenance reference guide specific to the IABP(s) based on the Operating Instructions Manual(s) provided with each device. These guides are also available on the Getinge.com web at the following address: https://info.getinge.com/ca-batteryguides
All concerned customers have received communication separately and there will be no cost for the customers for this recall. This information is released in order to inform users of mentioned Getinge products, according to standard procedure recommended by regulatory authorities.
Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions that aim to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.