Getinge heart pump has CE mark suspended by second notified body, halting sales for 3 months

Dive Brief:

TÜV SÜD has suspended the CE certificate for Getinge’s intra-aortic balloon pump Cardiosave for up to three months.
The notified body blocked sales of the heart pumps in markets that require CE marks over concerns related to risk management, post-market surveillance and vigilance and the timeliness of field safety corrective actions.
Munich-based TÜV SÜD took the step weeks after another notified body, DEKRA, temporarily suspended the CE certificates for Getinge life support sets over noncompliance with the Medical Device Directive.

Dive Insight:

Getinge has been beset by compliance problems over the past few years. The company’s intra-aortic balloon pumps have been the subject of three Class I recalls since 2021, most recently when it received complaints of blood entering the device during use. The blood can cause the device to stop working, and at the time of the recall, the problem had been linked to four serious injuries and one death.

Now, TÜV SÜD has temporarily stopped Getinge from selling its Cardiosave devices in some markets altogether, although pumps that are already on the market can continue to be used and devices already in distribution can be delivered.

The suspension covers territories that account for SEK 70 million ($6.6 million) in annual sales of the device, suggesting the three-month action could cost Getinge around $1.7 million. Getinge’s net sales exceeded $2.5 billion last year, and based on the current information, it does not expect the financial impact of the suspension to be material.

While the direct financial impact of the suspension is likely to be small for a business of Getinge’s size, the company acknowledged “the severe situation” the action puts on healthcare providers and critically ill patients. Cardiosave devices are used in patients undergoing cardiac and non-cardiac surgery, and to treat people with acute coronary syndrome or complications of heart failure.

Getinge is “in dialogue with TÜV SÜD and working urgently to minimize the impact on patients,” the company said. The company made a similar statement when DEKRA suspended the CE certificates for its life support sets.