The U.S. FDA posted a notice about an Abiomed recall for its Impella Left Sided Blood Pumps, categorizing it as a Class 1 recall, the most serious type of recall.

Abiomed issued the recall because the pumps’ instructions for use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR).

The IFU lacks guidance to clinicians on how to manage use of Impella in patients with TAVR and fails to describe how the issue may present if an Impella interacts with TAVR. There is a potential risk that the Impella motor housing may come into contact with the distal stent of a transcatheter aortic valve replacement (TAVR). The contact may damage or destroy the motor’s impeller blades.

The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream. Use of affected devices may cause serious injury or death.

Abiomed reported 30 complaints, 26 injuries, and four deaths related to this issue. Clinicians may continue to use the devices, with the additional instructions for patients with TAVR in mind. The product is not being removed from the field and does not need to be returned.

Customers are encouraged to:

  • Review, complete all fields, sign, and return the business response form to the recall coordinator identified in the notice.
  • Forward the notice to anyone in the facility who needs to be informed, including people who manage, transport, store, stock, or use the subject products.
  • If any of the subject products have been forwarded to another facility, contact that facility and provide them with the notice.
  • Post a copy of the notice in a visible area for awareness.

People who may be affected include those who receive ventricle and circulatory support from Impella Left Sided Blood Pumps and health care personnel providing care for people who receive support using the device.

Impella Left Sided Blood Pumps are used for short term support of the pumping chambers of the heart (ventricles) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI).

They are also used when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy. Impella therapy aims to reduce the work of the heart’s ventricles and provide support for the circulatory system so the heart has time to recover.

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