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# Abbott Recalls HeartMate 3 Pump Over Leaks
- URL: https://www.fdaweb.com/abbott-recalls-heartmate-3-pump-over-leaks/
- Published: 2024-05-15T12:00:00.000Z
- Updated: 2026-09-14T14:30:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156989

Abbott is recalling (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. “In all reported events, the issue was observed during implantation of the device,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-heartmate-3-left-ventricular-assist-system-lvas-implant-kit-risk-blood-leakage-or-air?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “Blood leakage or air entering the LVAD from this location will impact the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure, or air embolism.” It says that using a leaking device may cause serious injury or death. To date, Abbott has received 81 complaints, including 70 injuries and two deaths related to the issue.

The HeartMate device is used to help the heart pump blood when it is not able to do so on its own. It is intended for both short- and long-term support in pediatric and adult patients with severe left ventricular heart failure. It can also be used while waiting for a heart transplant.

FDA notes that the recall is a device correction and the company says that if a “blood leak or air entrainment is suspected or observed, follow standard surgical processes and the existing instructions for use (IFU). Residual air must be completely evacuated from the device blood chamber prior to initiating the LVAD support.”