· Heartmate 3 Implant kit Leakage Risk during LVAD surgery.
FDA Recall.
May 2024.
Abbott is recalling HM3 implant kit after complaints about blood leakage or air entering seal interface between LVAD inflow cannula and apical cuff.
All reported incidents occurred during the device's implantation.
Risks: Blood leakage or air entry at this site can compromise blood flow integrity, potentially leading to extended surgery, bleeding (hemorrhage), right heart failure, or air embolism.
The company issued an Urgent Medical Device Correction Notification letter advising the following:
1. Completely evacuate residual air from the device blood chamber before initiating LVAD support.
2. Use conventional strategies for addressing air leaks or surgical bleeding: adjusting the pump position, reversal of anticoagulation, adding surgical materials, and exchanging the apical cuff or pump as needed.
3. Always have a complete backup system (implant kit and external components) readily available on-site during the implantation procedure for emergency use.
Source:
