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Mar 31, 2024Medtronic identifies patients at increased risk of heart pump failure
Aug 21, 2023The company has recalled its HeartWare HVAD pump multiple times since it was pulled from the market in 2021.
Medtronic’s HVAD system is used in end-stage heart failure patients who are waiting for a heart transplant. The device consists of a pump implanted near the heart as well as a controller to manage the pump’s speed and function.
Medtronic previously identified two other subgroups of patients that face an increased likelihood of pump problems. One group, with 38 people, faced a 2.7% increased risk, while the other, with 17 people, faced a 31% increased risk.
Medtronic added a third subgroup after determining the pump failure rate for that group of patients had increased over time. All three groups of pumps flagged by the company share the same unnamed supplier, while other pumps that weren’t identified as having an increased risk were made by a different company.
In an FDA notice on Friday, the agency said that patients in one of the identified subgroups should contact their VAD coordinator if they need to make a controller exchange, so that it can take place in a clinical setting.