FDA-Device2023-11-15Class II
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
St. Jude Medical
Hazard
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Sold states
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, KUWAIT, NETHERLANDS, PORTUGAL, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM.
Affected count
36,153 units
Manufactured in
387 Technology Cir Nw Ste 500, Atlanta, GA, United States
Products
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0218-2024Don't want to check this manually?
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