The U.S. Food and Drug Administration has announced the recall of Medtronic’s HVAD Pump Implant Kit. The HVAD Pump Implant Kit was classified as a Class I recall, which is the most severe type of recall. The recall states that the use of these HVAD Pump Implant Kit could cause severe injury or death. The medical devices were recalled due to a welding defect. The models affected by the recall include 1101, 1103, 1104, 1104JP, and MCS1705PU. The distribution dates of the recalled HVAD Pump Implant Kit were from October 11, 2006, through June 03, 2021. More than 1,600 units have been recalled.
Medtronic’s HeartWare Ventricular Assist Device HVAD System is used to aid the heart in pumping blood throughout the rest of the patient’s body. The HVAD system was designed to work with cardiac transplants in patients who are at risk of end-stage left ventricular heart failure, to aid in heart tissue recovery, and for destination therapy (DT) in patients who are not currently candidates for heart transplant surgery.
Medtronic’s recall announcement states that their HVAD Pump Implant Kit has a manufacturing defect. After inspecting pumps that were returned to Medtronic showed that moisture entered the pump’s center post of the pump, leading to demagnetization and corrosion of the device’s internal magnets. This can cause incorrect pump rotation. Patients who have been implanted with the recalled devices can present with symptoms similar to pump thrombosis. Should the issue occur, the can pump malfunction causing injury or death. Some patients may need to undergo surgery to replace the HVAD system.
On April 11, 2022, Medtronic mailed an Urgent Medical Device Correction letter to specific health care providers who retained unused HVAD Pump Implant Kits. The letter urged the health care providers to return the unused devices for a refund.
On April 26, 2022, Medtronic mailed out an Urgent Medical Device Correction letter to all health care providers, informing them of the possible pump weld defect. The letter requested that if a patient presents symptoms described in the letter, the healthcare providers upload and submit all .csv log files to Medtronic. Physicians were also asked to consider whether a pump thrombus causes their patients’ symptoms and to treat accordingly. Physicians were asked to decide if removing or exchanging the recalled pump would be necessary based on the patient’s symptoms and surgical risks.
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