CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary art

FDA device recall Z-1225-2023 · posted 2023-03-06 · Open, Classified

Recall details

Recalling firm

St. Jude Medical

Reason for recall

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.

Action taken

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 Sensors.

Root cause

Device Design

Status

Open, Classified

Product code

MOM

Quantity affected

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, Netherl

Date initiated

2023-02-07

Date posted

2023-03-06

Location

Atlanta, GA