Saturday, April 20, 2024

Abiomed Announces Critical Update to Impella Blood Pumps Following Class I Recall Due to Ventricular Perforation Risks

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Abiomed has issued a crucial update concerning the Instructions for Use (IFU) for its Impella Left Sided Blood Pumps, aimed at addressing the serious risks of ventricular perforation. This action, classified by the FDA as a Class I recall, signifies the highest level of concern, as the use of these devices could lead to severe injuries or even fatalities. The update follows reports of potentially life-threatening complications, including the perforation of the left ventricle, a critical component of the heart’s pumping mechanism. This recall encompasses multiple models of the Impella blood pump, which are widely used in hospitals and clinics across the United States to provide support during complex cardiac procedures.

The decision to revise the IFU reflects Abiomed’s commitment to patient safety and underscores the importance of adhering to precise operational guidelines when utilizing these advanced medical devices. The recall and subsequent updates are aimed at ensuring that healthcare professionals are fully informed of the risks and proper usage techniques to minimize the likelihood of adverse outcomes for patients undergoing treatment with Impella blood pumps.

The recall affects a range of Impella blood pumps available in the U.S., including Impella 2.5, Impella CP models, and Impella 5.0 variants, among others, spanning product codes listed in the Recall Database Entry. These devices, distributed from October 10, 2021, to October 10, 2023, have seen 66,390 units recalled as of December 27, 2023. The Impella pumps are designed for temporary ventricular support during high-risk percutaneous coronary interventions and in cases of acute myocardial infarction, cardiomyopathy, or ongoing cardiogenic shock, aiming to alleviate the heart’s workload and facilitate recovery.

Blood Pump

Abiomed Implements Critical Updates on Impella Blood Pumps Following Reports of Ventricular Damage and Elevated Patient Risk

The recall stems from incidents where the pump catheter of the Impella devices risked perforating the heart’s left ventricle wall during surgical procedures. With 129 serious injuries reported, including 49 fatalities, the potential for severe adverse health outcomes such as left ventricle perforation, free wall rupture, and significant blood flow disruption is alarmingly high.

Patients undergoing procedures involving Impella Left Sided Blood Pumps, particularly those with anterior infarction, elderly individuals, and women, are identified as groups at heightened risk. To mitigate these risks, Abiomed’s Urgent Medical Device Correction letter dated December 27, 2023, instructs medical professionals on new and updated warnings. These include cautious pump catheter positioning, the use of imaging during catheter manipulation, and special insertion care for patients with high-risk conditions or those undergoing active CPR. Facilities are urged to review these revised instructions and ensure all pertinent staff are informed of the changes.

 

Resource: Food and Drug Administration, March 21, 2024

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