CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues
St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting a cardiac monitoring device. Although no injuries or hospitalizations have been reported, the data loss and duplication issues constitute a risk-of-harm scenario: physicians relying on inaccurate or missing patient hemodynamic data could make inappropriate treatment decisions for heart failure patients.
Plain-English summary
St. Jude Medical is recalling the CardioMEMS Heart Failure (HF) System, which includes the Hospital System Model CM3100, Backend Web Application Model CM4000, and Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000. This system measures pulmonary artery hemodynamic data to support the monitoring and management of heart failure patients. Approximately 193 devices have been distributed throughout the United States.
The recall was initiated due to issues encountered during the migration of patient information and results to a cloud service. St. Jude Medical has received complaints indicating that during this migration, some patient profile information was duplicated while other patient information became missing from the system.
Patients and healthcare providers using the affected CardioMEMS systems should contact the manufacturer or their healthcare provider for further guidance regarding their specific device. Affected devices can be identified by their serial numbers, which are detailed in the official FDA recall notice.
The recalled product
- Product
- CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary…
- Manufacturer
- St. Jude Medical
- Affected units
- 193
Distribution
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