US regulator issues highest alert for heart pump linked to 49 deaths

US regulator issues highest alert for heart pump linked to 49 deaths
US regulator issues highest alert for heart pump linked to 49 deaths

We show you our most important and recent visitors news details US regulator issues highest alert for heart pump linked to 49 deaths in the following article

Hind Al Soulia - Riyadh - NEW YORK — The US Food and Drug Administration (FDA) has issued its highest-level alert about a heart pump that has been linked to 49 deaths and 129 injuries.

The Impella left sided pumps are used to temporarily support a patient's heart during high-risk procedures or after a severe heart attack.

But the regulator warned it could puncture a wall in the heart's left ventricle if used incorrectly.

The device's manufacturer, Abiomed, has issued new instructions for the pump.

A summary posted on the FDA's website on March 21 classified the move as "most serious type of recall" because of the risk of serious injuries or death if the device is used incorrectly.

The agency warned that the use of affected pumps may also cause serious adverse health consequences, including "hypertension, lack of blood flow, and death".

But it added that the recall was a correction, not a product removal, and the device will remain on the market.

The notice relates to 66,390 devices that were distributed in the US over two years starting from Oct. 10, 2021, the agency said.

The device was given FDA approval in 2008.

The pump has a catheter with a small hook at the end, which is threaded through the blood vessels and in to the left ventricle — a key chamber in the heart used to pump blood full of oxygen around the body.

A spokesperson for Johnson & Johnson — which acquired Abiomed in 2022 — told Reuters: "This notification is not a device removal and Impella heart pumps remain on the market and available for patients."

Abiomed first disclosed the risk of heart perforation during insertion of the pumps in a technical bulletin posted in October 2021, but did not share this information with the FDA at the time, the agency said.

The agency carried out an inspection of the firm's office in Massachusetts in early 2023, and sent a warning letter to Abiomed in September where it criticized — among other things — a failure to update the FDA on the risk of heart perforation.

The warning letter resulted in the Abiomed issuing a "Urgent Medical Device Correction letter" late last year, containing revised instructions for using the heart pump correctly, including how to position the pump's catheter or use imaging when turning it during procedures, the FDA said. — BBC


These were the details of the news US regulator issues highest alert for heart pump linked to 49 deaths for this day. We hope that we have succeeded by giving you the full details and information. To follow all our news, you can subscribe to the alerts system or to one of our different systems to provide you with all that is new.

It is also worth noting that the original news has been published and is available at Saudi Gazette and the editorial team at AlKhaleej Today has confirmed it and it has been modified, and it may have been completely transferred or quoted from it and you can read and follow this news from its main source.

PREV Spain to end golden visas for foreign real estate investors
NEXT Barrage of Russian attacks aims to cut Ukraine's lights

Author Information

I have been an independent financial adviser for over 11 years in the city and in recent years turned my experience in finance and passion for journalism into a full time role. I perform analysis of Companies and publicize valuable information for shareholder community. Address: 2077 Sharon Lane Mishawaka, IN 46544, USA Phone: (+1) 574-255-1083 Email: [email protected]