Recall Z-1219-2023 ยท MOM System, Hemodynamic, Implantable
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, 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.
| Date | Mar 3, 2023 (initiated Feb 7, 2023) |
| Status | Open, Classified |
| 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). |
| Root cause | Device Design |
| 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. Custom |
| Quantity | 200 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.