Medtronic—HeartWare Ventricular Assist Device Controllers: May Develop Cracks, Potentially Permitting Fluid or Water Ingress If IFU Are Not Followed
September 12, 2018 | Strategic Insights for Health System
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In an August 2018 Important Medical Device Correction letter submitted by ECRI Institute member hospitals, HeartWare (now part of Medtronic) states that the above controllers may not meet labeled standard for protection against fluid or water ingress; some units may develop hairline cracks at the power ports of the controller housing, potentially permitting ingress if the patient does not follow the instructions for use (IFU) and Patient Manual with regard to using a water-resistant shower bag. If a controller develops a hairline crack and is unprotected from water or fluid exposure as described in the IFU, the unit may exhibit water or fluid ingress. Medtronic also states that the cracks may not be visible without magnification. Medtronic has resolved the root cause of this problem, and as of August 23, 2018, newly distributed controller units are no longer susceptible. Medtronic further states that it has received...