Medtronic has recalled its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief products, which are part of the HeartWare Ventricular Assist Device (HVAD) System. The system is used as a bridge to cardiac transplants in patients who are at risk of death due to end-stage left ventricular heart failure, heart tissue recovery or as destination therapy.
The product issue: The outflow graft of the HVAD Pump could tear, and the strain relief screw could break during assembly (but before implanted) and go unnoticed until during or after attachment to the HVAD pump. Medtronic has received 92 complaints related to the issue. Adverse effects include dizziness, bleeding, loss of consciousness, fluid buildup around the heart, more medical procedures and death. The FDA recall page does not mention any reported deaths as a result of the product issue.
The recall affects nearly 5000 HeartWare pump outflow graft and strain relief parts that were distributed between March 1, 2018 and April 1, 2020.
Related Articles
-
An analysis of the HVAD pump implant kit showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.
-
Medtronic will invest up to $75 million and immediately begin co-promotion of CathWorks’ FFRangio System for the noninvasive diagnosis of CAD in the U.S., Europe and Japan, where it is commercially available.
-
The CERSI program was established to foster robust and innovative approaches to advance regulatory science through collaborative interactions with FDA scientific experts.
-
The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current…
