Reported Mar 15, 2023 · Ongoing
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, 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 Patient Electronics System (PES), Model number CM1000, 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 05414734509169
- Serial Numbers
2,714 of 2,714 codes
M131100003M131100004M131100008M131100012M131100013M131100015M131200018M131200022M131200027M131200030M131200033M131200034M131200035M131200036M131200038M131200040M131200043M131200044M131200047M131200048M131200050M131200051M131200052M131200053M131200054M131200057M131200059M131200063M131200066M131200067M131200069M131200070M131200071M131200072M131200073M131200074M131200075M131200076M131200077M131200078M131200079M131200082M131200083M131200085M131200086M131200088M131200090M131200092M131200094M131200095M131200096M131200097M131200099M131200100M131200102M131200103M131200105M131200106M131200108M131200109
- Amount recalled
- 3,177 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
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 and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
This product could cause temporary or reversible health problems — stop using it.
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