FDAFDA · Food and drugs·Recall number Z-0830-2025
Impella RP Flex with SmartAssist; Product Number: 1000323;
Published January 22, 2025 · Recall initiated: December 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abiomed, Inc.
- Distributor
- Domestic: Nationwide Distribution International: Canada
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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