Impella RP with SmartAssist recall
Impella RP with SmartAssist; Product Number: 0046-0035;
Why was Impella RP with SmartAssist recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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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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, 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- Product
- Impella RP with SmartAssist; Product Number: 0046-0035;
- Recalling firm
- Abiomed, Inc.
- Quantity
- 1,560 units
- Distribution
- Domestic: Nationwide Distribution International: Canada
- Recall date
- January 22, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)