FDA alerts to Class I recall of Instructions for Use for Impella Left Sided Blood Pumps due to risk of injury, death

According to the FDA, Abiomed has recalled the Instructions for Use for its Impella Left Sided Blood Pumps, in six (6) different types, out of concern that the pump catheter may puncture the wall of the heart’s left ventricle, particularly during operations.

Those who use an impacted Impella pump put themselves at risk for major adverse health consequences, such as a perforation in the heaty’s left ventricle, or a “free wall rupture.” Other associated health outcomes include “hypertension, lack of blood flow, and death.”

To date of the FDA announcement, Abiomed has received 129 reports of serious injuries linked to the product. 49 of those reports include deaths.

Indicated for short-term support of the heart’s pumping chambers (ventricles), particularly during high-risk procedures in which catheters are used, also known as percutaneous coronary interventions (PCI), Impella Left Sided Blood Pumps are also used typically used in the event of ongoing cardiogenic shock. A patient may fall under such shock within 48 hours of a major heart attack (“acute myocardial infarction”), during open-heart surgery, or during sub-optimal heart functioning due to cardiomyopathy, a disease of the heart muscle. In response to the risks of such conditions, Impella therapy was developed with the aim to facilitate the functioning of the heart’s ventricles and support the circulatory system during heart recovery. Each kind of Impella pump serves a different therapeutic purpose.

The FDA has identified those believed to be impacted by the recall:

  • Individuals undergoing procedures that make use of an Impella Left Sided Blood Pump
  • Individuals who suffer from anterior infarction (heart disease)
  • Women and elderly individuals

An Urgent Medical Device Correction letter by Abiomed was sent to all affected customers on December 27, 2023. The communication urged users to carefully read and adhere to the revision in the Instructions for Use:

  • Maintain careful placement of the pump catheter during operations
  • When advancing or torquing the pump catheter, use imaging
  • When inserting the pump catheter in patients who suffer from high-risk condition, or when CPR is being administered.
  • Review all updates in the Instructions for Use
  • Ensure that all relevant staff at a given facility–including at those facilities where products have been forwarded–is informed of the correction

Further consumer questions my be addressed to Abiomed customers at (978) 646-1400.

As the FDA continues to monitor the problem, the agency asks that healthcare professionals ad consumers report any related adverse reactions to its MedWatch program.


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