CLASS I ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Impella RP Flex with SmartAssist recalled by Abiomed
Abiomed is recalling Impella RP Flex with SmartAssist, distributed nationwide in the US. The recall was initiated on 12 Dec 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0830-2025
- FDA event ID
- 95780
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Dec 2024
- FDA classified
- 15 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 12 Dec 2024 | Recall initiated by company | |
| 15 Jan 2025 | Classified by FDA | +34 days |
| 22 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Impella RP Flex with SmartAssist; Product Number: 1000323;
Where it was distributed
Domestic: Nationwide Distribution International: Canada
Questions about this recall
Why was it 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.
Which lots are affected?
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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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;
Where was it sold?
Domestic: Nationwide Distribution International: Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95780| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Impella RP with SmartAssist recalled by Abiomed | Abiomed | Device Malfunction | Nationwide |
More recalls from Abiomed
All 70| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Introducer Kit, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Impella CP Smart Assist Set, JP, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Intro Kitand, PKGD, JP, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Impella 5.5 Smart Assist Set, JP, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Impella CP Set, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |