CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings
St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.
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 for a medical device that produces incorrect pressure readings, posing a risk of harm to heart failure patients. No illnesses or injuries have been reported in the source text.
Plain-English summary
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System, which includes the CardioMEMS HF System Hospital Electronics System (HES) (Model MN6000) and associated Merlin.net Patient Care Network web application. A total of 431 units have been distributed in the United States nationwide and internationally in Australia and Canada.
During a cloud data migration of patient and hospital electronic systems, the systems were reverted to an outdated configuration. This reversion caused the CardioMEMS system to produce incorrect and inaccurate pulmonary artery (PA) pressure readings.
The CardioMEMS system is used to monitor heart failure patients. Clinicians and patients using affected systems should contact St. Jude Medical or the FDA for guidance on verifying system configuration and ensuring accurate pressure readings.
The recalled product
- Product
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF…
- Manufacturer
- St. Jude Medical
- Affected units
- 431
Distribution
Part of a larger recall action
This product is one of 2 recalled by St. Jude Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · St. Jude Medical
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Same hazard · incorrect pressure readings
See all →- HighSmiths Medical blood sampling system recalled for pressure reading errors
FDA (Devices) · 2021-10-20
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