Medical Device Network

FDA issues warning on Getinge device amid quality concerns

Following a series of voluntary recalls, the FDA has urged healthcare providers to avoid Getinge’s intra-aortic balloon pumps over safety concerns.

The US Food and Drug Administration (FDA) has urged healthcare providers not to use certain Getinge devices amid concerns that the company’s devices still pose a risk to users despite a previous recall.

In a statement published on 8 May, the FDA urged healthcare providers to move away from using the Cardiosave Hybrid and Rescue intra-aortic balloon pump (IABP) by Swedish company Datascope, as it continues to receive reports of concern following a recall.

It is also warning clinicians to move away from Getinge’s cardiopulmonary bypass (CPB) devices, including the Getinge Cardiohelp system and HLS Sets. The FDA says that over the last 12 months, the FDA has received 2,964 medical device reports (MDR) related to Cardiosave IABPs, of those, 15 were reported as resulting in patient serious injury or death.

From 1 January 2023, Getinge has initiated 12 voluntary recalls in the US for the Cardiosave IABP. The FDA classified eight as a Class I recall - the most serious type of recall. Since then, the authority has continued to receive reports of concern.

The FDA said that some of the reports describe Cardiosave IABP devices shutting down, it has also been evaluating other concerns with the IABP, including blood entering the device, which can cause the device to rupture, or the patient or clinician provider being exposed to patient blood.

In a statement, the FDA said: “The FDA continues to work with the Getinge to understand factors contributing to the device failures, as well as possible mitigation strategies.

“The FDA worked with the US Department of Justice to place Getinge manufacturing sites under a consent decree in 2015 and added the IABP manufacturing site in 2022. This action allows additional FDA oversight, an independent auditor, inspections, and updates on progress made toward addressing quality and safety concerns. At this time, the cardiopulmonary bypass and IABP facilities have not met the requirements to have the consent decree lifted.”

Elsewhere, Getinge has seen its CE certificate suspended over similar concerns after it had previously reinstated the company’s market authorisation following three months of working alongside certification body TÜV SÜD. In July 2023, the EU reinstated the company’s CE mark but has now withdrawn it for a second time due to gaps identified in compliance with applicable regulations.

The issues followed Getinge's acquisition of an EU Medical Device Regulation (MDR) certificate for its Advanta V12 covered stent system designed specifically for patients living with aortoiliac occlusive disease.