Recall archive / FDA device enforcement

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary ... — FDA record Z-1224-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, 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.
Reason: 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.
Classification: Class II
Recalling firm: St. Jude Medical
Quantity: 1905 units
Agency-reported status: Ongoing
Source record identifier: Z-1224-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, M140800895, M140800896, M140800918, M140800919, M140800922, M140800925, M140800926, M140901157, M140901158, M140901159, M140901160, M140901161, M140901162, M140901163, M140901164, M140901166, M140901169, M140901172, M140901174, M140901175, M140901177, M140901184, M140901185, M140901186, M141001337, M141001339, M141001341, M141001344, M141001345, M141001353, M141001354, M141001355, M141001356, M141001358, M141001359, M141001360, M141001361, M141001362, M141001363, 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M160807684, M160807685, M160807687, M160807690, M160807692, M161107927, M161107928, M161107929, M161107930, M161107931, M161107932, M161107933, M161107934, M161107935, M161107936, M161107937, M161107938, M161107939, M161107940, M161107941, M161107942, M161107943, M161107944, M161107945, M161207947, M161207948, M161207953, M161207955, M161207956, M161207957, M161207958, M161207959, M161207960, M161207961, M161207962, M161207963, M161207964, M161207965, M161207968, M161207969, M161207970, M161207972, M161207973, M161207974, M161207975, M161207976, M161207978, M161207980, M161207981, M161207983, M161207984, M161207985, M161208049, M161208065, M161208066, M161208067, M161208068, M161208069, M161208070, M161208071, M161208072, M161208073, M161208074, M161208075, M161208076, M161208077, M161208078, M161208079, M161208080, M161208081, M161208082, M161208084, M170108086, M170108087, M170108088, M170108089, M170108090, M170108091, M170108092, M170108093, M170108095, M170108096, M170108097, M170108098, M170108100, M170108101, M170108102, M170108103, M170108104, M170108106, M170108107, M170108108, M170108109, M170108110, M170108111, M170108112, M170108113, M170108114, M170108115, M170108119, M170108120, M170108122, M170108123, M170108124, M170108125, M170108126, M170108127, M170108130, M170108131, M170108132, M170108133, M170108134, M170108135, M170108136, M170108137, M170108138, M170108140, M170108141, M170108142, M170108144, M170108145, M170108146, M170108147, M170108148, M170108149, M170108150, M170108153, M170108154, M170108155, M170108156, M170108157, M170208158, M170208159, M170208160, M170208161, M170208162, M170208163, M170208164, M170208165, M170208166, M170208167, M170208168, M170208169, M170208170, M170208171, M170208172, M170208173, M170208174, M170208175, M170208176, M170208177, M170208178, M170208179, M170208181, M170208182, M170208183, M170208184, M170208185, M170208187, M170308188, M170308190, M170308191, M170308192, M170308193, M170308194, M170308195, M170308196, M170308197, M170308200, M170308201, M170308202, M170308203, M170308204, M170308205, M170308206, M170308207, M170308208, M170308209, M170308210, M170308211, M170308212, M170308213, M170308214, M170308215, M170408216, M170408217, M170408218, M170408219, M170408220, M170408222, M170408223, M170408224, M170408225, M170408226, M170408227, M170408228, M170408229, M170408230, M170408231, M170408232, M170408233, M170408234, M170408235, M170408240, M170408241, M170408242, M170408243, M170408244, M170408246, M170408249, M170408250, M170408252, M170408253, M170408254, M170408255, M170408256, M170408257, M170408259, M170508260, M170508261, M170508275, M170608293, M170608294, M170608295, M170608296, M170608297, M170708308, M170708309, M170708310, M170708311, M170708313, M170708314, M170708315, M170708316, M170708317, M170708321, M170708323, M170708339, M170808325, M170808326, M170808328, M170808329, M170808336, M170808337, M170808338, M170808340, M170808341, M170808342, M170808344, 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M180108467, M180108468, M180108469, M180108470, M180108471, M180108472, M180108474, M180208475, M180208476, M180208479, M180208480, M180208481, M180208482, M180208483, M180208484, M180208485, M180208488, M180208489, M180208491, M180208492, M180208493, M180208494, M180208495, M180208497, M180208498, M180208499, M180208501, M180208502, M180208503, M180208504, M180208505, M180208506, M180208507, M180208509, M180208510, M180208511, M180208512, M180208514, M180208517, M180308526, M180308527, M180308529, M180308535, M180308537, M180308539, M180408540, M180408543, M180408544, M180408545, M180408546, M180408549, M180408551, M180408552, M180408553, M180408554, M180408555, M180408556, M180408557, M180408562, M180408574, M180408575, M180408576, M180408577, M180408578, M180408579, M180408580, M180408583, M180408584, M180408585, M180408586, M180408587, M180408588, M180408589, M180408590, M180408591, M180508593, M180508596, M180508598, M180508600, M180508601, M180508602, M180508603, M180508604, M180508605, M180508606, M180508607, M180508608, M180508611, M180508617, M180508619, M180508620, M180508627, M180508629, M180508630, M180508631, M180608632, M180608634, M180608635, M180608637, M180608638, M180608639, M180608642, M180608643, M180608644, M180608645, M180608646, M180608647, M180608648, M180608649, M180608651, M180608652, M180608653, M180608655, M180608656, M180608657, M180608658, M180608659, M180608660, M180608661, M180608662, M180608663, M180608667, M180608668, M180608669, M180608670, M180608671, M180608672, M180608673, M180608674, M180608677, M180608678, M180608679, M180608680, M180608681, M180608683, M180608684, M180608689, M180608690, M180608691, M180608692, M180608693, M180608694, M180608697, M180608698, M180608699, M180608700, M180608701, M180608702, M180608707, M180608708, M180608710, M180608711, M180608712, M180608713, M180608714, M180608717, M180608718, M180608719, M180608720, M180608721, M180608722, M180608723, M180608724, M180608725, M180608726, M180608727, M180608728, M180608730, M180608731, M180608732, M180608734, M180608735...

Label field

Details supplied by the agency

Lot, code or applicability

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, M140800895, M140800896, M140800918, M140800919, M140800922, M140800925, M140800926, M140901157, M140901158, M140901159, M140901160, M140901161, M140901162, M140901163, M140901164, M140901166, M140901169, M140901172, M140901174, M140901175, M140901177, M140901184, M140901185, M140901186, M141001337, M141001339, M141001341, M141001344, M141001345, M141001353, M141001354, M141001355, M141001356, M141001358, M141001359, M141001360, M141001361, M141001362, M141001363, M141001366, M141201849, 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M160807687, M160807690, M160807692, M161107927, M161107928, M161107929, M161107930, M161107931, M161107932, M161107933, M161107934, M161107935, M161107936, M161107937, M161107938, M161107939, M161107940, M161107941, M161107942, M161107943, M161107944, M161107945, M161207947, M161207948, M161207953, M161207955, M161207956, M161207957, M161207958, M161207959, M161207960, M161207961, M161207962, M161207963, M161207964, M161207965, M161207968, M161207969, M161207970, M161207972, M161207973, M161207974, M161207975, M161207976, M161207978, M161207980, M161207981, M161207983, M161207984, M161207985, M161208049, M161208065, M161208066, M161208067, M161208068, M161208069, M161208070, M161208071, M161208072, M161208073, M161208074, M161208075, M161208076, M161208077, M161208078, M161208079, M161208080, M161208081, M161208082, M161208084, M170108086, M170108087, M170108088, M170108089, M170108090, M170108091, M170108092, M170108093, M170108095, M170108096, M170108097, M170108098, M170108100, 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M180608731, M180608732, M180608734, M180608735...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 15, 2023
Recall initiation date: Feb 7, 2023
Center classification date: Mar 6, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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