FDA Announces Recall of Heart Devices After 49 Deaths Reported

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A notice said there were 129 ’serious injuries’ that were reported, too.

The U.S. Food and Drug Administration announced the recall of more than 66,000 heart pumps after dozens of deaths were reported, as the agency described it as the “most serious type of recall.”

Abiomed, a subsidiary of pharmaceutical giant Johnson & Johnson, said in the FDA notice that it is recalling instructions for certain Impella left-sided blood pumps over serious safety issues that have led to 129 “serious injuries” along with 49 death reports.

“During operations, the Impella device could cut through the wall of the left ventricle,” the company’s notice stated. “The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”

The Impella pumps are used in some high-risk heart procedures to provide short-term support.

The use of the affected pumps may also cause serious adverse health consequences, including hypertension, lack of blood flow, and death, according to the federal health regulator’s notice.

The recall targets 66,390 Impella devices distributed to customers between October 2021 and October 2023. The products included in the recall advisory include Impella LD, Impella 5.0, Impella 5.5 with SmartAssist, Impella 2.5, Impella CP, and Impella CP with SmartAssist.

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FDA Classifies Recall of Abiomed’s Blood Pumps as Most Serious

The FDA classified the recall as a Class I recall, or the most serious kind. “Use of these devices may cause serious injuries or death,” the FDA wrote in the notice on March 20.

But the agency said that it is “a correction” and “not a product removal.” Because it is not a full product removal, it means the devices can be used to treat patients as long as healthcare providers use revised or new warnings that are provided to customers under the recall.

“This notification is not a device removal and Impella heart pumps remain on the market and available for patients,” a spokesperson for Johnson & Johnson, which oversees Abiomed, told Reuters. The company said it had updated instructions for the use of the Impella system to further address the potential risk of a rare complication, left ventricular perforation.

Consumers will have to use an Urgent Medical Device Correction sent by Abiomed to customers in December 2023, the bulletin said.

The new instructions and warnings say that the pump needs to be carefully positioned during operations, using imaging when “advancing or torquing the pump catheter,” and other requirements. Users of the pump also should notify “everyone at your facility who needs to be informed of this recall correction,” it says.

Abiomed sells other pumps under the Impella brand, which are used for different therapeutic reasons. Johnson & Johnson struck a massive $16.6 billion all-cash deal in 2022 to buy Abiomed to boost growth in its medical devices unit. Abiomed operates as a standalone business under J&J’s MedTech unit.

The company issued a separate statement about the recall.

“Abiomed has updated our [instructions for use] for our Impella system to further address the potential risk of a rare complication, left ventricular (LV) perforation,” the company said.

“With patient safety top of mind, our [instructions for use] has been updated with stronger technical guidance around implantation and repositioning and emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella,” it continued. “This notification is not a device removal and Impella heart pumps remain on the market and available for patients.”

Other Alerts

Earlier this week, in a updated warning, the FDA said that it has concerns that some made-in-China syringes have the potential for “device failure,” such as breakage, leaks, and “other problems.”

“The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body,” the notice said.

It noted that consumers and healthcare providers should “consider using syringes not manufactured in China, if possible” because of the potential problems.

Reuters contributed to this report.

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