Medtronic HVAD Recall
In April 2022 Medtronic issued a recall while notifying doctors and patients of an investigation of the HeartWare Ventricular Assist Device (HVAD), a device used to help the heart to continue pumping blood to the rest of the body.
Previous to the most recent recall announcement, Medtronic stopped selling and distributing HVAD given the increasing risks of serious injuries and mortality. Due to the issues that the device was causing, there were already multiple other FDA recall notices regarding the device.
The latest recall happened after Medtronic received three complaints of patients with symptoms resembling the outcome of pump thrombosis, a major device defect.
A welding defect was identified, allowing moisture to enter the center post of the pump causing corrosion of the internal magnet.
Symptoms include the following:
-Elevated lactate dehydrogenase (LDH)
-Low motor speed resulting in low perfusion
-Abnormal pump sounds such as grinding or excess vibration
-Transient power spikes on the log files and high watt alarms
If you are using a Medtronic HVAD Pump Implant Kit and experiencing any of the above symptoms, consult your primary care physician.
Medtronic HVAD recall is considered by FDA as a Class I recall.
Models recalled so far are: 1101, 1103, 1104, 1104JP, MCS1705PU. Distributed between October 11, 2006, to June 3, 2021.
As of right now, there are 14 deaths as a result of using the recalled device.
Injury Attorneys at Messa & Associates
If you or a loved one have been injured by this or any other defective product, contact an attorney at Messa & Associates. Our law firm is ready and willing to fight the toughest lawyers for the biggest companies because we are Philadelphia’s toughest injury firm. Call us directly at 877-637-7252 for a free consultation or submit an online inquiry for a free case evaluation.