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Abbott has identified that a subset of Assurity and/or Endurity pacemaker(s) are impacted by a manufacturing issue.  As background, the issue in this recall is connected to a manufacturing laser roughening process, unique to a single assembly site…

A bug has been detected in the planning software. When loading images, there may be a left/right inversion. Display of image series is flipped after importing a sagittal oriented image series stored using the enhanced Dicom format. Recall start date:…

Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da vinci s/si and x/xi Endowrist clip applier instruments. Intuitive has received several complaints…

Smiths Medical implemented a design change in 2016 to widen the hinge assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added to the H-1000 model. Smiths Medical has become aware that…

Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Medtronic is informing customers of product performance issues related to the Heartware Ventricular Assist Device (HVAD) system batteries. Medtronic is taking actions to address two separate battery issues: 1) a weld nonconformance has been identified…

Our contract manufacturer sent us a FSCA identifying deviations in their sterilisation process and therefore we can not guarantee the sterility of the products. Recall start date: May 18, 2022

Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend…

Dräger has become aware of one case in which an obstructed Breathing System Filter Safestar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated. If an obstructed filter is used on a patient,…

The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to…

Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of…

Bias flow selection for NO system usage is missing from the user interface of Fabian HFOi Ventilators following incorrect selection of device configuration during a software update. This is caused by human error and there is no defect in the device or…

Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery…

Potential for injury if the MR system is incorrectly deinstalled. Recall start date: Mar 10, 2022

Potential for injury if the Mr system is incorrectly deinstalled. Recall start date: Mar 10, 2022