Cardiac devices

UNITED STATES – The medical device manufacturer Maquet is recalling thousands of cardiac devices called intra-aortic balloon pumps (IABPs) due to battery issues that could be life-threatening to patients. The U.S. Food and Drug Administration announced the recall in May 2019 because of concerns that the devices could lose charge and stop working, exposing patients to serious risk.

Maquet, which is a subsidiary of the company Getinge, has included more than 22,800 IABPs in the recall. IABPs are devices used to treat heart failure complications and acute coronary syndrome in patients having surgery. It appears the devices might malfunction in battery mode because of unexpected draining of the batteries, abnormal battery life, or charging issues.

Since March 2016, Maquet has received five reports of patient death potentially linked to battery issues with its IABPs. Maquet indicated that these reports have not been definitively traced back to failures in the devices alone. However, the company indicated that it was recalling the devices to make sure that its manuals are clear and are being followed.

Included in the current recall are the following devices:

• Cardiosave Hybrid Intra-Aortic Balloon Pump
• Cardiosave Rescue Intra-Aortic Balloon Pump
• CS300 Intra-Aortic Balloon Pump
• CS100/100i Intra-Aortic Balloon Pump

The recall does not require that products be returned to the manufacturer. Maquet said it would be contacting all customers with recalled IABPs to schedule training, during which company representatives will review battery care operations, maintenance procedures, and general use guidelines.

Maquet is reportedly working to develop new software for its Cardiosave batteries, which the company expects to be available in an upgrade released sometime in 2020. The FDA has to first clear the software update, after which representatives for Maquet will contact customers to discuss how to install the upgraded software.