Impella Devices Recalled After Deaths, Injuries Tied to TAVR Interactions

More Impella left-sided blood pumps are under Class I recall, this time for potential interactions with transcatheter aortic valve replacement (TAVR) stents, the FDA announced Thursday.

The affected devices include nearly 8,000 blood pumps marketed as Impella 5.0, Impella CP, Impella 2.5, Impella CP with SmartAssist, Impella LD, or Impella 5.5 with SmartAssist — all mechanical circulatory support devices that can be used temporarily for cardiogenic shock, percutaneous coronary intervention, and open-heart surgery.

Device maker Abiomed recalled these Impella pumps because their “Instructions for Use” do not adequately address precautions to take when treating patients who have existing TAVR implants.

Motor damage may occur if the device comes into contact with the distal stent of the TAVR system, which could lead to reduced blood flow or the pump stopping. What’s more, pieces of the motor’s broken blades could enter the patient’s bloodstream.

Abiomed already reported 30 complaints, 26 injuries, and four deaths related to this issue, according to the FDA.

Instead of pulling devices from the field, the company issued an Urgent Medical Device Correction notice informing clinicians that they may continue to use the Impella pumps if they follow additional instructions to avoid Impella-TAVR interactions, including:

• Positioning the Impella system carefully in TAVR patients
• Avoiding repositioning while the device is spinning
• Turning the device to P0 during repositioning or any movement that could bring the outlet windows into proximity to the valve stent structures
• Replacing the Impella if low flow is observed and there is possible device damage

The Impella 5.5 with SmartAssist had been subject to an earlier Class I recall due to 179 complaints of purge fluid leaks that result in low purge pressures that can lead to pump stop. Abiomed coordinated product returns related to that recall.