Daily Newsletter

11 August 2023

Daily Newsletter

11 August 2023

Fourth recall this year for Getinge’s beleaguered Cardiosave IABPs

More unexpected shutdowns of the devices mean 4586 have been recalled in a Class I recall.

Robert Barrie August 11 2023

Datascope, a subsidiary of Getinge, has encountered more regulatory problems following the US Food and Drug Administration (FDA)’s decision to label the recall of the company’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I.

The devices, which inflate the left ventricle at a set rhythm to help the heart pump blood, have been reported to unexpectedly shut down due to an electrical failure. If this happens, bloody supply to the body could be interrupted. The FDA said in its alert that continued use of the devices might cause serious injury or death.

The FDA stated: “Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death.”

The recall, which involves 4586 devices sold between March 2012 to May 2023, adds to three previous Class I recalls for the devices. The first, in January, involved more than 4,400 devices due to a faulty catheter.  There were two more recalls in March relating to the same issue of the most recent recall. Unlike the recall in January which caused four serious injuries and one death, the August recall has only had 26 complaints.

A letter was sent to customers of the Cardiosave Hybird and Cardiosave Rescue products that asked to make sure an alternative IABP or haemodynamic support is available to continue therapy.

Cardiosave IABPs are indicated for cardiac and non-cardiac surgery, acute coronary syndrome, or complications of heart failure in adults.

In March 2023, the devices had its CE mark suspended until Getinge adhered to corrective actions.

Healthcare companies are hesitant to invest in the metaverse

The COVID-19 pandemic pushed the healthcare industry to rapid digitalization. Increased use of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology is changing how healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment of psychological and neurological disorders. In the pharma and medical devices industries, AR, VR, and AI are rapidly accelerating drug discovery and manufacturing and generating supply chain efficiencies. New digital opportunities will look to build upon disruptive technologies. However, affordability is a limiting factor to widespread adoption. Per GlobalData estimates, the metaverse market is expected to grow at a CAGR of more than 33% between 2023 and 2030. Although metaverse technologies could reinvent healthcare approaches and bring new experiences to healthcare providers and patients, adoption is still at an early stage. There are currently few use cases in the healthcare industry. The metaverse needs to overcome major challenges for healthcare, including regulation and data privacy concerns. Evidence of proven use cases and participation by a critical mass of users are imperative to drive a shift in metaverse investment.

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