Sam Brusco, Associate Editor06.08.22
The FDA has identified Medtronic’s recall of the HVAD pump implant kit as Class I.
Medtronic recalled the 1,614 devices beginning on April 11. They were distributed from October 11, 2006 to June 3, 2021. Thus far Medtronic has received three complaints regarding this problem, including one death and two injuries.
The HeartWare ventricular assist device (HVAD) helps the heart continue pumping blood to the rest of the body. It’s used as a bridge to cardiac transplant for patients at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy for patients who don’t plan to have heart transplants.
The HVAD pump implant kit was recalled over a pump weld defect. After inspection of explanted pumps, analysis showed moisture entered the pumps center post causing corrosion and demagnetization of the internal magnets, which can cause the pump to rotate incorrectly. Patients using affected devices may show signs and symptoms resembling pump thrombosis.
If this occurs it can lead to pump malfunction, death, severe injury (shock with severe organ dysfunction, stroke), or require major surgery to replace the pump.
In Medtronic’s April 26 Urgent Medical Device Correction Letter, customers were requested to upload and submit .csv logfiles when patients present with the listed signs and symptoms.
They were also urged to consider whether patients presenting with the signs and symptoms could be caused by pump thrombus and make decision about removing or exchanging the HVAD on a case-by-case basis.
Medtronic recalled the 1,614 devices beginning on April 11. They were distributed from October 11, 2006 to June 3, 2021. Thus far Medtronic has received three complaints regarding this problem, including one death and two injuries.
The HeartWare ventricular assist device (HVAD) helps the heart continue pumping blood to the rest of the body. It’s used as a bridge to cardiac transplant for patients at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy for patients who don’t plan to have heart transplants.
The HVAD pump implant kit was recalled over a pump weld defect. After inspection of explanted pumps, analysis showed moisture entered the pumps center post causing corrosion and demagnetization of the internal magnets, which can cause the pump to rotate incorrectly. Patients using affected devices may show signs and symptoms resembling pump thrombosis.
If this occurs it can lead to pump malfunction, death, severe injury (shock with severe organ dysfunction, stroke), or require major surgery to replace the pump.
In Medtronic’s April 26 Urgent Medical Device Correction Letter, customers were requested to upload and submit .csv logfiles when patients present with the listed signs and symptoms.
They were also urged to consider whether patients presenting with the signs and symptoms could be caused by pump thrombus and make decision about removing or exchanging the HVAD on a case-by-case basis.