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

Class I - Dangerous

🏥 Medical Devices Recalled: December 12, 2024 Abiomed Other Medical Devices Nationwide

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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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Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Abiomed, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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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461126, 461127, 460030, 460032, 460034, 459666, 460031, 460036, 460037, 460038, 459668, 460040, 459667, 459671, 459672, 459674, 444540A, 459730, 459572, 459573, 459725, 459726, 459727, 459728, 459729, 459566, 459662, 459663, 459664, 459567, 459568, 459570, 459655, 459660, 459661, 459731, 459732, 459733, 459734, 459657, 459658, 459659, 459571, 459363, 459364, 459365, 459366, 459367, 459370, 459381, 459385, 459386, 459382, 459387, 459368, 459369, 459383, 459384, 459389, 459390, 459195, 459193, 459194, 459196, 459190, 459191, 459208, 457733, 459189, 459192, 459207, 457511, 457734, 457509, 457512, 459205, 459206, 457728, 457729, 457731, 457732, 459202, 459203, 459204, 457508, 457513, 457515, 457727, 459361, 459362, 457503, 457505, 457498, 457499, 457506, 457496, 457497, 457500, 456135, 456134, 456136, 456137, 456139, 456140, 456141, 456206, 456132, 456202, 456203, 456207, 456092, 456095, 456097, 456210, 456211, 456801, 456093, 456094, 456208, 456803, 457396, 457400, 457403, 456069, 456098, 456099, 456100, 456800, 457405, 457404, 455614, 455615, 455616, 455618, 456062, 456063, 456065, 456067, 456068, 456064, 455609, 455610, 442270A, 454308, 455574, 455575, 454307, 443794, 454306, 455570, 455571, 455573, 455577, 454299, 454302, 454673, 455569, 454303, 454304, 454674, 454678, 454680, 454681, 454677, 454682, 451712, 451713, 451715, 451716, 453978, 453982, 453983, 451711, 453976, 453977, 454015, 454019, 454021, 454023, 455325, 455328, 455321, 451717, 455320, 455324, 451665, 451667, 451668, 451669, 451671, 448756, 448762, 451666, 452467, 452470, 452472, 452473, 448753, 448754, 448755, 451673, 448661, 451218, 451219, 452558, 452560, 452561, 451212, 451215, 452476, 448656, 448657, 448658, 448660, 448663, 451210, 448654, 450016, 450017, 450363, 450364, 450355, 450357, 450358, 450360, 450361, 450362, 442215, 442217, 442218, 427706A, 446244, 446245, 446246, 446249, 446549, 446242, 446243, 446540, 446545, 446547, 446548, 446240, 446248, 446542, 446241, 446247, 446920, 446921, 446925, 446926, 446927, 446928, 449911, 449915, 449912, 449909, 449913, 449914, 449918, 446395, 446397, 446398, 446404, 445897, 445898, 445906, 445899, 445900, 445905, 445901, 445902, 445903, 445904, 444833, 444831, 444830, 444775, 444777, 445888, 445890, 445893, 445894, 444769, 444796, 444798, 444793, 444795, 444791, 443496, 442498, 442730, 442731, 443497, 443498, 443499, 443502, 440916, 442493, 442494, 443504, 443505, 443796, 444539, 444543, 442500, 442724, 444541, 444544, 444546, 444548, 442725, 442727, 443590, 443631, 443586, 443592, 443594, 443595, 443627, 443628, 443630, 443633, 443635, 444529, 443800, 444530, 444532, 444533, 444534, 443792, 443795, 443797, 443798, 443799, 444535, 444536, 444531, 444537, 444538, 442276, 442274, 442275, 442281, 442279, 442263, 442273, 442267, 442268, 442271, 440909, 440912, 440914, 440907, 440911, 436350, 437774, 440329, 440330, 440331, 440333, 440334, 436342, 436345, 437775, 437776, 437777, 437779, 437780, 436344, 436347, 436348, 434310, 434308, 434309, 427420, 434212, 434219, 434311, 434312, 434313, 434213, 434214, 434215, 434216, 434217, 434218, 434306, 434307, 434211, 434284, 434286, 434287, 434288, 434289, 434290, 434291, 434292, 434293, 427418, 428696, 432885, 432886, 432891, 432888, 432890, 427411, 427412, 428698, 432887, 432892, 427365, 427409, 427410, 428699, 428702, 427360, 427364, 427366, 428693, 428695, 428357, 428359, 428362, 428364, 428355, 428356, 431686, 431687, 431688, 431689, 431690, 431691, 428935, 428936, 428938, 431692, 428939, 428940, 431107, 431110, 431114, 431113, 431115, 431684, 432880, 432881, 432882, 426557, 431685, 432875, 432876, 432877, 432878, 427423, 427425, 427426, 427428, 427709, 427708, 427710, 427419, 427421, 427422, 427427, 427707, 428928, 428931, 428934, 428926, 428933, 427711, 427712, 427713, 428925, 428333, 428334, 428335, 428338, 428341, 428342, 428336, 428337, 416217A, 426564, 426562, 426565, 426558, 426560, 426563, 426556, 422560, 427107, 427106, 427111, 422557, 422544, 422729, 422736, 422548, 427102, 422552, 422728, 422558, 422559, 427109, 427110, 422545, 422547, 422550, 422551, 422734, 422735, 422546, 422549, 422727, 422730, 425774, 425259, 424879, 424881, 424883, 424884, 425258, 425780, 424548, 424885, 425254, 425257, 424546, 424547, 424887, 424888, 425261, 425850, 425854, 425260, 425771, 425779, 425852, 425855, 425857, 425858, 425853, 423325, 423608, 423609, 423865, 424539, 424545, 410463, 423601, 423602, 423866, 421655, 423606, 423870, 423872, 423874, 424540, 423607, 423868, 423871, 423321, 423322, 423326, 423329, 423330, 423867, 423869, 424541, 424542, 424543, 424544, 421657, 421658, 421659, 421660, 421661, 413759A, 417581, 417582, 417583, 417584, 417586, 417588, 417579, 422155, 422156, 422157, 422554, 422154, 422158, 422159, 422160, 422553, 422152, 422556, 422561, 419372, 421652, 421653, 421654, 422142, 422145, 422146, 419368, 419370, 419377, 419373, 419374, 422147, 422149, 422150, 422148, 422143, 422144, 421168, 418886, 421163, 421165, 421169, 420317, 421160, 421167, 418887, 418888, 418889, 420318, 420319, 421161, 421162, 420313, 420314, 419990, 420311, 420312, 420315, 419989, 419983, 419985, 419986, 420310, 420316, 415264, 415266, 417877, 417878, 415257, 415259, 415261, 415262, 415263, 415260, 418446, 418448, 418883, 416214, 416221, 417882, 417884, 417885, 417886, 418884, 418885, 416215, 416216, 416218, 416220, 416223, 418440, 418441, 418444, 418445, 414298, 414299, 413709, 414296, 414301, 414303, 414985, 414987, 414983, 414984, 414992, 414304, 414305, 414988, 414989, 414990, 406483, 406484, 397113, 413701, 413702, 413703, 413704, 413705, 413706, 412898, 412899, 412901, 412894, 412902, 412903, 413707, 412895, 412896, 412897, 399628, 418124, 418125, 418126, 418127, 418128, 418129, 418131, 418132, 403394, 418133, 415228, 415229, 415234, 415235, 410458A, 412261, 413754, 413756, 413757, 413758, 415227, 413755, 415231, 415232, 415233, 415236, 409387, 412266, 412505, 412509, 412511, 413750, 413752, 413753, 413683, 413685, 410454, 413688, 412259, 412263, 410455, 410456, 411139, 412264, 412503, 412504, 412506, 413686, 413687, 413689, 413680, 413681, 413682, 411142, 411144, 411147, 410457, 410459, 411141, 411143, 410461, 410462, 411140, 409935A, 401564, 411138, 401563, 401566, 410094, 410095, 410096, 410099, 410100, 410102, 411092, 410103, 411093, 411094, 411095, 411096, 401759, 411088, 411089, 411090, 401757, 401758, 411091, 401753, 401754, 401760, 401761, 411097, 401755, 401756, 409940, 409395, 401559, 401560, 401561, 409248, 409389, 409390, 409391, 409394, 409936, 409937, 409941, 409938, 408876, 408878, 409393, 409939, 409944, 402230, 408873, 408874, 409245, 409388, 409392, 408871, 408875, 408879, 409942, 409943, 402225, 402227, 408353, 402229, 408354, 409243, 409247, 409249, 409250, 408576, 409105, 402476, 402483, 409102, 409103, 409104, 409106, 409108, 402475, 402481, 408577, 408580, 408583, 408584, 408585, 409107, 402474, 402479, 402480, 402482, 407024, 408158, 408161, 407019, 407021, 407023, 407025, 408156, 408157, 405865, 405866, 405868, 405869, 405870, 407018, 408164, 405863, 405871, 405872, 408162, 408163, 408165, 408357, 408358, 402224, 402231, 402232, 406491, 408356, 408359, 405060, 405061, 405062, 406489, 406486, 406487, 406490, 406483, 406484, 406482, 403467, 405059, 405055, 405056, 405058, 403464, 403465, 403468, 405054, 403073, 403074, 403075, 403079, 403080, 394644, 394645, 394640, 394641, 394643, 401999, 402000, 403461, 403463, 402002, 402004, 402005, 402007, 403071, 403401, 403460, 403394, 403398, 403399, 403400, 403402, 394646, 394649, 403393, 403397, 401079, 401083,

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0829-2025

Related Recalls

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.

Abiomed

Class I - Dangerous

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Sep 16, 2025 Other Medical Devices Nationwide View Details →

Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432.

Abiomed

Class I - Dangerous

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Oct 1, 2025 Infusion Pumps Nationwide View Details →

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.

Abiomed

Class I - Dangerous

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

Aug 20, 2025 Infusion Pumps View Details →