Search
Type
Audience
Category
Issue
Last updated
Recall class
Please note: using the search filters may not provide accurate search results for records prior to November 2021. When searching for older records, please ensure that you use the include archive checkbox.
Displaying 1 - 5 of 5 items.
Cardiomems Patient and Hospital Electronics System
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
Cardiomems Hospital Electronics System
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
Tacticath Contact Force Ablation Catheter, Sensor Enabled
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
Dragonfly Opstar Imaging Catheter
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
AMPLATZER STEERABLE DELIVERY SHEATH
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