Reported Mar 15, 2023 · Ongoing
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary…
St. Jude Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical · 387 Technology Cir Nw Ste 500 · Atlanta, GA · 30313-2424
Is this the product you have?
- CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, 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.
- Lot codes and dates
- UDI/DI 05415067029331
1,905 of 1,905 codes
M140100179M140100180M140100181M140100182M140100183M140100184M140100185M140100186M140200187M140200188M140200190M140200191M140200193M140200196M140200204M140200205M140200213M140200215M140200216M140200218M140200220M140200221M140200223M140200224M140200226M140200228M140200230M140200233M140200234M140200235M140200237M140200238M140200240M140200243M140200245M140400469M140400470M140400471M140400472M140400474M140600522M140600530M140600532M140600536M140600537M140600538M140600541M140600542M140600543M140600545M140600546M140700687M140700688M140700689M140700690M140700691M140700692M140700693M140700694M140700698
- UDI/DI 05415067029331
- Amount recalled
- 1905 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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