St. Jude Medical recalls
7 official recalls and safety alerts involving St. Jude Medical since 2023-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with St. Jude Medical or the relevant agency.
- 2025-04-02
USSt. Jude Medical recalls CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model…
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient…
FDA · DeviceSt. Jude MedicalU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice →- 2025-01-29
- US
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care…
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
FDA · DeviceSt. Jude MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - US
St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System…
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
FDA · DeviceSt. Jude MedicalU.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/AOfficial notice → - 2024-07-24
- US
St. Jude Medical recalls St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
- 2023-11-15
- US
St. Jude Medical recalls CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure…
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
FDA · DeviceSt. Jude MedicalWorldwide distribution - US Nationwide and the countries of ARGENTINA,…Official notice → - 2023-03-15
- US
St. Jude Medical recalls CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA)…
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…
FDA · DeviceSt. Jude MedicalWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
St. Jude Medical recalls CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA)…
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…
FDA · DeviceSt. Jude MedicalWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →