Recall Z-1225-2023 ยท MOM System, Hemodynamic, Implantable
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, 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 6, 2023 (initiated Feb 7, 2023) |
| Status | Open, Classified |
| Reason | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties. |
| 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 do the following: 1. Prior to the implantation procedure, sensor data should be entered, and the clinician should proceed to the next screen to complete the Error #8 screening, prior to venipuncture. 2. If an Error #8 message occurs, the sensor should not be implanted. 3. Work with your Abbott Sales Representative to exchange the affected sensor. 4. Review Appendix B for labeling and supplemental information related to implantation and monitoring of CardioMEMS PA S |
| Quantity | 317 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.