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St. Jude Medical recalls CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmo
Recalled November 15, 2023 · FDA recall Z-0218-2024 · St. Jude Medical
Hazard
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. · FDA Class II
Units
36,153 units
Sold at
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.
Description
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Product
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Manufacturer(s)
St. Jude Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →