BEUDAMED
    FDA Recall Open, Classified

    CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    Recall: Z-1218-2023 · Initiated February 7, 2023

    Recall

    Recall Number
    Z-1218-2023
    Event Number
    91610
    Firm
    St. Jude Medical
    FEI Number
    3004936110
    Product Code
    MOM
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 7, 2023
    Posted
    March 3, 2023
    Address
    387 Technology Cir Nw, Ste 500, Atlanta, GA, 30313-2424

    Description

    CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    Reason

    Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).

    Action

    Abbott notified consignees on about 02/07/2023 via hand-delivery of the letter within the US. The letter instructed consignees to continue to follow CardioMEMS Instructions for Use (IFU). Abbott will notify patients of the emissions issue. If you suspect a CardioMEMS Electronics System has interfered with another medical device during use, report the event to Abbott Remote Care Technical Support at 1-844-MYCMEMS (692-6367) (US). Customers were also instructed to complete and return the acknowledgement and receipt form. Abbott notified patients on about 02/07/2023 via mailed letter. Customers were instructed that they could continue use of their CardioMEMS System and that their doctor has been notified of the issue as well. If there is suspicion that interference may be occurring during a sensor reading or any other quality issues, please report it to: Abbott Technical Support at 1-844-MYCMEMS (692-6367) (US); Monday-Friday: 8am-8pm EST

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates.

    Quantity

    3,177 units