Medtronic’s spate of HeartWare heart pump issues continues with battery recall

After issuing near-monthly safety warnings related to its discontinued HeartWare Ventricular Assist Device (HVAD) last year, Medtronic is already continuing the trend in 2023. The heart pump’s first recall this year arrived last week, when Medtronic sent a letter (PDF) to a handful of ventricular assist device coordinators representing several healthcare facilities. The devicemaker is asking those customers to return certain HVAD batteries that have been identified as having a welding issue that could potentially cause the batteries to malfunction. Only 12 batteries distributed around the world are included in the recall, which Medtronic began in order to continue its “engineering analysis” of the faulty batteries.This recall builds on a pair of safety notices that Medtronic sent to healthcare providers last summer.In May, the company recalled a single lot of HVAD batteries, comprising 429 in total, with plans to replace them with new components. In a letter (PDF) at the time, Medtronic said it had discovered a welding defect that could prevent the battery from recharging properly or holding a complete charge, or even cause it to no longer provide any power whatsoever.


Click here to continue reading:

Παλαιότερα άρθρα