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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates. Quantity: 1905 units Lot/code info: UDI/DI 05415067029331: M140100179, M140100180, M140100181, M140100182, M140100183, M140100184, M140100185, M140100186, M140200187, M140200188, M140200190, M140200191, M140200193, M140200196, M140200204, M140200205, M140200213, M140200215, M140200216, M140200218, M140200220, M140200221, M140200223, M140200224, M140200226, M140200228, M140200230, M140200233, M140200234, M140200235, M140200237, M140200238, M140200240, M140200243, M140200245, M140400469, M140400470, M140400471, M140400472, M140400474, M140600522, M140600530, M140600532, M140600536, M140600537, M140600538, M140600541, M140600542, M140600543, M140600545, M140600546, M140700687, M140700688, M140700689, M140700690, M140700691, M140700692, M140700693, M140700694, M140700698, M140700699, M140700700, M140700701, M140700703, M140700705, M140700710, M140700712, M140700713, M140700714, M140700715, M140700717, M140700718, M140700721, M140700722, M140700725, M140700726, M140700799, M140700800, M140700801, M140700804, M140700806, M140700817, M140700818, M140800820, M140800821, M140800822, M140800825, M140800827, M140800828, M140800829, M140800833, M140800835, M140800837, M140800838, M140800839, M140800841, M140800842, M140800846, M140800848, M140800849, M140800850, M140800853, M140800855, M140800856, M140800859, M140800861, M140800862, M140800864, M140800867, M140800868, M140800869, M140800872, M140800874, M140800876, M140800877, M140800879, M140800880, M140800881, M140800883, M140800886, M140800887, M140800890, M140800891, M
05415067029331
Official record: FDA (Device enforcement) ↗
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