Abiomed recalls LVADs for motor damage risk after contact with TAVR stent
Key takeaways:
- Abiomed announced a recall of its LVAD due to instructions for use that lack guidance when treating patients who underwent TAVR.
- The recall is a correction, not a product removal.
Abiomed announced a recall of its left ventricular assist device due to instructions for use that do not adequately address device use in patients who have undergone transcatheter aortic valve replacement.
The FDA has identified the recall as class I, the most serious type of recall, as use of affected devices may cause serious injury or death.
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The recall does not involve the removal of already implanted devices, the company told Healio.
The LVAD’s (Impella) instructions for use (IFU) lack guidance on how to manage use of the device in patients who have undergone TAVR and fails to describe what may happen if the LVAD interacts with a TAVR. According to the release, there is a potential risk that LVAD motor housing may come into contact with the distal stent of a TAVR, causing damage to or destroying the motor’s impeller blades.
Damage to the impeller blades may reduce blood flow or cause the pump to stop. This may be life-threatening as it may delay therapy or fail to provide enough support to the patient. Pieces of the broken blades could also enter the patient’s bloodstream, according to the release.
The FDA release stated that clinicians may continue to use the LVAD, with the additional instructions for patients with TAVR in mind.
The recall includes 7,895 devices distributed from May 1, 2021, to present.
The company reports 30 complaints, 26 injuries and four deaths related to this issue.
The company issued the following statement to Healio by email:
“At Abiomed, our first priority is our patients, including the safe and effective use of our products. On June 14, we issued a notification to customers regarding the safe use of left sided Impella heart pumps in patients with a transcatheter aortic valve replacement (TAVR) valve. The notification addresses the potential risk for unintentional interaction of the Impella motor housing with the distal stent of a previously implanted TAVR valve and provides further recommendations on how to position Impella in these patients.
“This notification was not a device removal. These devices remain available and Impella technology can continue to be used safely in patients with a previously implanted TAVR valve.”
Editor’s Note: This article was updated on July 28, 2023 to add the statement from Abiomed.