St. Jude Medical: CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.

Hazard

Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.

Details from the source

Reason for recall: Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. Distribution: 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. Quantity: 36,153 units Lot/code info: Model Number CM1100; UDI/DI: 05414734509800; Serial Numbers: P150800220, P150800222, P150800226, P150800240, P150800242, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800273, P150800277, P150900313, P150900315, P150900318, P150900319, P150900322, P150900333, P150900334, P150900335, P150900337, P150900343, P150900344, P150900349, P150900350, P160100406, P160100410, P160100412, P160100414, P160100416, P160100419, P160100422, P160200429, P160200434, P160200435, P160200440, P160200442, P160200451, P160200452, P160200453, P160200456, P160200459, P160200464, P160200466, P160200469, P160200476, P160200479, P160200480, P160200486, P160200487, P160200488, P160200489, P160200490, P160200493, P160200498, P160200505, P160200511, P160200512, P160200515, P160200518, P160200521, P160200524, P160200527, P160200528, P160200529, P160200530, P160200535, P160200538, P160200539, P160200540, P160200545, P160200548, P160200552, P160200557, P160200559, P160200565, P160200566, P160200568, P160200569, P160200571, P160200573, P160200575, P160500583, P160500596, P160500597, P160500601, P160500602, P160600606, P160600607, P160600608, P160600609, P160600610, P160600612, P160600621, P160600622, P160600625, P160600626, P160600632, P160600633, P160600636, P160600638, P160600643, P160600646, P160600647, P160600656, P160600658, P160600659, P160600663, P160600664, P160600668, P160600669, P160600676, P160600678, P160600681, P160600682,

UPC codes

05414734509800

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.