Exact FDA event identifier

Event 95780

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 12, 2024
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Abiomed, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Impella RP with SmartAssist; Product Number: 0046-0035;

Z-0829-2025

Recall number: Z-0829-2025
Initiated: December 12, 2024
Classification: Class I
Status: Ongoing
Recalling firm: Abiomed, Inc.
Quantity: 1,560 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 0046-0035; UDI-DI: 00813502011869; Serial Numbers: 492884, 492882, 492883, 522056, 522054, 522055, 522106, 522107, 522110, 522111, 522105, 522109, 520014, 520017, 520018, 520019, 520020, 520021, 520022, 520023, 520747, 520748, 520743, 520744, 520746, 520739, 520740, 520664, 520742, 520660, 520661, 520663, 520666, 520668, 518497, 520659, 520665, 518500, 518501, 518496, 518494, 518499, 518502, 518503, 518963, 518960, 518961, 518962, 518959, 518958, 518955, 518956, 507392, 518954, 507386, 507389, 507390, 507391, 507385, 507384, 507393, 492683, 492682, 492681, 492680, 489923, 489921, 489919, 489918, 489916, 489917, 489915, 492677, 492679, 492674, 509155, 509156, 509157, 509151, 509154, 509149, 491454, 509148, 509150, 491456, 491457, 491458, 491455, 491460, 491461, 491462, 491463, 486724, 486717, 486718, 486721, 476036, 476038, 476034, 476035, 476033, 476032, 476031, 489894, 489892, 489893, 489889, 491433, 491437, 489886, 489887, 489888, 491431, 491432, 491436, 484301, 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Distribution pattern

Domestic: Nationwide Distribution International: Canada

device · product 2 of 2

Impella RP Flex with SmartAssist; Product Number: 1000323;

Z-0830-2025

Recall number: Z-0830-2025
Initiated: December 12, 2024
Classification: Class I
Status: Ongoing
Recalling firm: Abiomed, Inc.
Quantity: 2,364 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

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, 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503897, 504446, 504447, 504789, 504792, 502037, 502038, 502039, 502040, 503838, 503839, 503840, 503841, 503842, 496231, 496232, 496233, 496234, 496235, 496236, 496237, 496238, 509256, 509257, 509248, 509249, 509250, 509251, 509253, 509340, 509341, 509343, 509344, 509345, 509346, 509347, 492444, 492445, 492446, 492447, 492449, 492451, 492452, 492453, 494355, 494357, 494359, 494356, 494358, 494363, 489561, 489563, 489564, 489565, 489566, 489567, 489568, 493861, 493862, 493863, 493865, 493866, 493867, 493868, 493869, 494344, 494345, 494346, 494349, 494351, 494353, 495835, 495836, 495837, 495838, 495839, 496665, 496667, 496668, 496669, 495162, 495164, 495168, 496243, 495163, 495830, 495070, 495075, 495076, 495161, 495831, 495073, 495074, 495165, 495311, 495317, 496247, 495069, 495166, 495309, 495310, 495316, 495318, 496242, 496249, 495078, 495832, 495833, 495071, 495072, 494376, 495135, 495136, 495138, 495139, 495141, 495143, 495142, 494375, 494369, 494370, 494372, 494373, 494374, 494377, 494378, 495140, 495159, 493530, 493532, 493533, 493534, 493975, 493529, 493970, 493527, 493528, 493531, 493535, 493526, 493974, 493979, 488964, 492487, 492492, 494335, 492485, 493191, 494338, 493186, 492484, 493187, 493193, 494337, 492493, 492488, 492490, 492491, 494334, 494341, 492486, 492489, 493188, 493189, 493192, 493194, 492206, 492207, 492208, 492209, 492211, 490454, 490456, 490457, 490459, 490460, 490461, 490462, 492205, 442295A, 490455, 490458, 484758, 484763, 484765, 484766, 492252, 492627, 492629, 492253, 492633, 492246, 484761, 492244, 492245, 492248, 492625, 492626, 492630, 492631, 492251, 490250, 490247, 490243, 490244, 490246, 490248, 490249, 490245, 490251, 489554, 490446, 488989, 488992, 488993, 489545, 489546, 489547, 489548, 489549, 489551, 490254, 490255, 490256, 490257, 490258, 490259, 490447, 490448, 490452, 488987, 488988, 488991, 489553, 490260, 490449, 490450, 490262, 490444, 490445, 488968, 490434, 490437, 490438, 490441, 490442, 490439, 488966, 488967, 486478, 488608, 488732, 488965, 486475, 486477, 488607, 488609, 488733, 488734, 488962, 486476, 488725, 488729, 486470, 486471, 486473, 488600, 488601, 488602, 488726, 488727, 488728, 488730, 488731, 488960, 488604, 488605, 488606, 488603, 485106, 485108, 483967, 485107, 485111, 484291, 484292, 485110, 483968, 485109, 485387, 485388, 483961, 483964, 483965, 483966, 485102, 485103, 485105, 485382, 485383, 485390, 485391, 483959, 483960, 485104, 484290, 485386, 484284, 484285, 484288, 484289, 484293, 485384, 482360, 482361, 488583, 488587, 483299, 483300, 483301, 483305, 488585, 482356, 483302, 483312, 483313, 483315, 483963, 488581, 483307, 483317, 482352, 482358, 482359, 483298, 483308, 483309, 483310, 483316, 488584, 482354, 482355, 482357, 486114, 486120, 485692, 485694, 485695, 486109, 486112, 486115, 486117, 486121, 486125, 486129, 486130, 486131, 486135, 486136, 485697, 485699, 486118, 486122, 486124, 486128, 486132, 486133, 485693, 485700, 485701, 486107, 488586, 488589, 482203, 482346, 482350, 482351, 482198, 482206, 482338, 482348, 482204, 482205, 482197, 482199, 482334, 482344, 482202, 482333, 482337, 482332, 482335, 482339, 482341, 482345, 482347, 482142, 482145, 482147, 482193, 444471, 484756, 482146, 482148, 482225, 484747, 444470, 482190, 482191, 482217, 482223, 482224, 484751, 484754, 444477, 444469, 482150, 482192, 482218, 482220, 482189, 482219, 444472, 482149, 484749, 444473, 444474, 444475, 444476, 444478, 482187, 482221, 484750, 484752, 484753, 444241, 443183, 443184, 443188, 444246, 444247, 444788, 443185, 443187, 443191, 443492, 444243, 444248, 444784, 443192, 443487, 443488, 444244, 444245, 444816, 454662, 444810, 454653, 454654, 454661, 444811, 454604, 454648, 454649, 454650, 454657, 454659, 444818, 454643, 444815, 454655, 452533, 452539, 452457, 452458, 452459, 452461, 452462, 452463, 452464, 452465, 452530, 452536, 449676, 449679, 453939, 453940, 442458, 442459, 449675, 449682, 451977, 453933, 449890, 442453, 449895, 449898, 442202, 442203, 442204, 442455, 449896, 452037, 452039, 452041, 452042, 442206, 442207, 452035, 442209, 442210, 442211, 442457, 452034, 452036, 441272, 441273, 440011, 440167, 440168, 440169, 440171, 440172, 440173, 440174, 441276, 441279, 441281, 441275, 439837, 439840, 440927, 440929, 440931, 440935, 442258, 440932, 441322, 441324, 441326, 441327, 442292, 442293, 441323, 442294, 442298, 442299, 442300, 442301, 442421, 442257, 442416, 442417, 442419, 442420, 442422, 442413, 442414, 442418, 439833, 439839, 440005, 439835, 440003, 440006, 439538, 439541, 439543, 439495, 439497, 439498, 439499, 439500, 439535, 439537, 440984, 440985, 439536, 438640, 438642, 438646, 438837, 438838, 438841, 440191, 438835, 438840, 439006, 439007, 439008, 439009, 436502, 439004, 439005, 438644, 438648, 438843, 439002, 440189, 438647, 440187, 436875A, 438842, 439000, 439001, 438607, 438606, 437526, 438608, 437531, 438777, 438773, 437528, 437530, 437799, 438645, 438771, 437796, 438600, 438776, 437794, 438770, 438775, 437800, 438778, 437792, 437801, 438769, 437793, 436512, 436508, 436510, 436515, 436877, 436879, 436880, 436873, 436874, 436506, 436507, 436509, 436514, 436876, 436881, 437523, 436511, 436501, 436504, 436505, 436500, 436503, 436498, 437788, 437791, 434516A, 437540, 437783, 437784, 437786, 437561, 437558, 434512, 437535, 434510, 434511, 436093, 433954, 434517, 433949, 436101, 433952, 433953, 436094, 437541, 434508, 434831, 436096, 436098, 436100, 437537, 437536, 437539, 437538, 436092, 436097, 434513, 437529, 433955, 434514, 434515, 434805, 436148, 433751, 433748, 434808, 436146, 434799, 436151, 436149, 436150, 436143, 434837, 436145, 434832, 434838, 434834, 434836, 436142, 434833, 433923, 433926, 434830, 433925, 434806, 433927, 434801, 434800, 434802, 434803, 433753, 432652, 433749, 433752, 433754, 434543, 434545, 434546, 433757, 434538, 434541, 434542, 433755, 433756, 434540, 432645, 432646, 432648, 432643, 432644, 429654, 429652, 432650, 432651, 429653A, 432400, 432401, 432402, 432397, 432398, 429646, 429648, 429650, 429649, 429651, 430363, 430366, 430362, 430367, 430365, 432394, 432396, 430360, 432393, 432395, 431848, 431847, 431846, 431845, 431536, 431844, 431851, 431868, 431870, 431537, 431849, 431850, 431869, 431535, 431843, 431531, 431529, 431530, 431532, 431533, 431534, 431099, 431101, 431098, 431103, 428725, 431106, 431105, 431104, 428730, 428731, 428733, 428726, 428729, 428734, 425591, 425592, 425593, 425595, 425596, 425599, 430927, 430929, 430931, 425600, 429616, 429617, 429619, 429620, 430922, 430923, 430924, 429621, 430926, 429623, 424002, 424006, 424000, 424004, 424007, 422974, 422975, 422978, 422979, 422972, 423999, 423998, 424001, 422981, 422980, 418933, 418935, 418937, 418939, 418934, 418938, 418941, 418940, 419490, 419491, 419496, 421953, 419489, 419495, 421955, 419494, 420695, 420696, 420697, 421960, 420698, 420699, 421958, 421952, 421957, 421956, 409537, 409541, 409543, 409544, 409546, 416645, 416646, 416653, 416644, 416650, 409542, 416647, 416649, 416651, 411373, 411374, 411376, 411377, 411372, 411378, 411379, 411380, 410413, 410411, 410412, 410408, 410409, 410405, 410410, 410406, 410407, 407255A, 407988A, 407991A, 407989A, 407994A, 407253A, 407992A;

Distribution pattern

Domestic: Nationwide Distribution International: Canada