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Displaying 1 - 6 of 6 items.
Abbott has received complaints from patients who are unable to exit MRI mode, as their patient controller has lost the ability to connect or communicate with their IPG while in MRI mode. Abbott sent a customer communication on 2023-07-21 to remind health…
RecallHealth product recall | 2023-08-15
Abbott has identified that when the Cardiomems Patient Electronics Systems (model CM1100) and Cardiomems Hospital Electronics Systems (HES) (model CM3000) are used to take a reading with the pulmonary artery (pa) sensor, the radiofrequency (RF) emissions…
RecallHealth product recall | 2023-02-23
The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have operated outside of this intended radiofrequency range at…
RecallHealth product recall | 2023-02-23
Abbott is voluntarily recalling affected lots of the Tacticath Contact Force Ablation Catheter, Sensor Enabled (models A-TCSE-DF and A-TCSE-DD). In certain instances, the Tacticath Contact Force Ablation Catheter, Sensor Enabled generates an error when…
RecallHealth product recall | 2022-07-04
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…
RecallHealth product recall | 2022-04-25
The Hemostasis valve in the closed position is not fully sealed and additional steps are required to prevent air ingress. Abbott is providing instructions (including update to the product instructions for use [IFU] and additional product…
RecallHealth product recall | 2021-11-19