FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
Braun Corporation (Braun) is recalling certain 2017-2018 BraunAbility Dodge Companion Vans built on Dodge RT minivan chassis. The brake lines may not be connected to the corresponding ports on the hydraulic control unit, causing reduced performance of the electronic stability control (ESC) system. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 135, "Light Vehicle Brake Systems," and 126, "Electronic Stability Control Systems."
Daimler Trucks North America LLC (DTNA) is recalling certain 2018-2019 Freightliner Business Class M2 trucks. The steering shaft assembly may have been installed incorrectly, which can cause a loss of connection between the steering wheel and the front wheels.
Keystone RV Company (Keystone) is recalling certain 2019 Keystone Summerland recreational trailers, models 1800BH, 1760BH, 1750RD. These trailers have single propane bottle brackets with two mounting legs that may break at the mounting point.
Forest River, Inc. (Forest River) is recalling certain 2019 Forest River Cherokee Wolf Pup recreational trailers, models CKTR15SW-D, CKTR16BHS-D, CKTR16FQ-D, CKTR18RJB-D and CKTR18TO-D. These trailers have single propane bottle brackets with two mounting legs that may break at the mounting point.