FDAFDA · Alimentos y medicamentos·N.º oficial Z-0830-2025
Impella RP Flex with SmartAssist; Product Number: 1000323;
Publicado el 22 de enero de 2025 · Inicio del retiro: 12 de diciembre de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Abiomed, Inc.
- Distribuidor
- Domestic: Nationwide Distribution International: Canada
- Lote
- Product Number: 1000323; UDI-DI: 00813502012811; Serial Numbers: 551121, 551122, 551123, 551124, 551125, 551127, 551128, 551129, 537606, 537610, 537612, 537615, 537607, 537608, 537609, 537613, 537614, 548547, 548548, 548550, 548553, 548554, 548555, 548556, 548552, 548559, 548560, 548561, 548562, 548563, 548564, 548565, 549638, 549640, 549641, 549642, 549643, 548558, 546672, 546675, 546676, 546678, 546679, 546680, 547552, 547556, 547558, 547559, 547560, 546652, 546654, 546656, 546657, 546658, 546659, 547561, 549644, 549646, 549647, 546661, 547563, 547564, 547566, 547567, 547568, 547569, 547570, 547571, 546681, 547189, 547191, 547192, 547193, 547194, 547195, 548827, 548830, 548831, 548834, 548835, 548836, 543714, 543716, 543719, 543720, 543721, 543722, 547169, 547170, 547171, 547172, 547173, 547174, 547188, 548188, 548189, 548196, 545799, 545800, 545801, 545802, 545803, 545804, 548191, 548192, 548193, 548194, 545486, 545488, 545795, 545796, 545797, 529171, 529172, 529174, 529175, 529179, 545475, 545478, 545481, 545482, 545483, 545489, 545490, 545491, 545492, 545494, 539350, 539352, 539353, 539354, 539355, 543274, 543275, 543276, 543277, 543278, 543279, 543282, 529170, 543273, 543283, 543284, 543286, 544125, 544126, 544130, 539356, 539357, 539358, 539359, 539794, 539795, 539797, 539799, 544123, 544124, 544127, 538387, 538388, 538389, 539790, 539791, 539792, 539793, 538381, 538382, 538383, 538384, 538385, 538386, 543285, 543288, 543289, 543292, 535401, 535403, 535404, 535405, 535407, 539820, 539822, 539823, 539824, 539825, 539826, 539829, 535408, 535409, 535410, 537995, 539800, 539801, 539803, 539806, 539809, 528198, 528199, 535421, 535425, 535427, 535428, 537993, 539805, 537992, 539807, 539808, 531407, 531410, 531411, 531413, 537996, 537997, 537999, 528191, 528192, 528193, 528194, 528195, 531414, 531415, 533140, 533141, 533142, 536414, 536415, 536416, 536417, 536418, 536419, 532106, 533074, 533075, 533079, 533134, 533135, 533137, 533138, 533139, 537973, 537974, 537976, 537980, 538376, 544138, 544139, 544140, 538371, 538372, 538375, 538377, 538378, 538380, 539340, 539341, 539344, 539345, 539347, 539348, 536531, 536534, 536535, 536536, 536537, 539784, 533081, 533082, 533083, 539785, 539786, 539788, 539789, 544131, 544132, 544133, 544134, 544135, 544940, 544941, 544942, 544944, 544945, 544947, 544950, 544952, 544954, 544955, 544957, 544958, 518335, 518337, 518338, 518339, 518340, 518341, 518342, 518343, 544948, 544949, 537661, 537663, 537664, 516715A, 518326A, 518328A, 518329A, 518330A, 518332A, 518333A, 516709A, 516712A, 518476A, 518477A, 518479A, 518480A, 518481A, 518482A, 516706A, 516707A, 516708A, 516767A, 516768A, 516769A, 516770A, 516771A, 516773A, 516774A, 518474A, 518475A, 536560, 536563, 536566, 536568, 536711, 537665, 537666, 537667, 537668, 537669, 535272, 535273, 536712, 536713, 536714, 536715, 536717, 536718, 533798, 533800, 533801, 533804, 533805, 535274, 535275, 535276, 535277, 535278, 535279, 531698, 531702, 531703, 531704, 531705, 531706, 533806, 533807, 531707, 535155, 535156, 535157, 535158, 535160, 535162, 535164, 536719, 531425, 531426, 531417, 531418, 531419, 531420, 531421, 535793, 535794, 535796, 535797, 535800, 535761, 535763, 535765, 535767, 535770, 535791, 535792, 535768, 535769, 524385, 526612, 526614, 526615, 526617, 526618, 528640, 528641, 528643, 526611, 529503, 530051, 530052, 530054, 530055, 530056, 530057, 530059, 526609, 526610, 527878, 527879, 527875, 527876, 527877, 529915, 529916, 529919, 529920, 529921, 529922, 529923, 531728, 531730, 531731, 531732, 531733, 531734, 531735, 531736, 533405, 533406, 533407, 533408, 533409, 533410, 533412, 533413, 530680, 530681, 530682, 530684, 530685, 530687, 530688, 530689, 526179, 526185, 533044, 533045, 533046, 533047, 533049, 533520, 533522, 533523, 533524, 533529, 526180, 526181, 526182, 526184, 526186, 526187, 527870, 527871, 527872, 532099, 532100, 532101, 532102, 536392, 536393, 536394, 536396, 536398, 533050, 533051, 533052, 533053, 527945, 527949, 5286
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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