Abiomed, Inc. recalls Impella RP Flex with SmartAssist
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Lot / code information
- UDI
- 00813502012811
- Serial #
551121, 551122, 551123, 551124, 551125, 551127 — +2358 moreShow all
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, 528646, 528647, 528648, 528649, 529726, 529727, 529729, 529730, 529731, 529732, 529733, 529734, 527940, 527941, 527943, 527946, 527947, 527948, 529502, 529505, 529507, 529509, 529500, 529501, 529504, 529506, 529508, 528181, 528184, 528185, 528186, 528187, 528189, 529181, 529182, 529183, 529184, 529185, 529186, 529187, 529188, 529189, 530040, 530041, 530048, 527003, 529071, 529072, 529073, 529074, 529075, 529076, 529077, 530046, 530049, 524378, 524386, 527001, 527002, 527004, 527005, 527006, 527007, 524377, 524379, 524380, 524381, 524383, 524384, 524804, 524807, 524808, 524809, 524810, 524811, 524812, 521358, 524803, 524805, 524806, 521356, 521357, 521360, 521361, 521362, 521363, 521354, 521355, 521359, 525187, 525188, 525189, 525192, 525038, 525039, 525041, 525045, 525046, 525191, 525193, 525194, 525195, 525196, 526620, 526624, 526621, 526623, 526626, 526628, 526619, 521314, 521315, 521316, 521317, 521318, 521320, 521321, 521322, 521323, 521872, 521874, 526173, 526174, 521875, 521876, 521877, 521878, 521879, 521880, 524181, 524182, 524183, 524184, 524185, 525824, 525830, 525833, 526175, 526176, 526177, 526178, 519279, 519282, 519284, 519286, 519287, 519288, 521245, 525825, 525827, 525828, 525831, 525832, 519280, 519281, 519285, 521240, 521241, 521243, 521244, 521246, 521247, 525808, 525809, 526993, 526995, 526996, 526997, 525805, 525806, 525810, 525811, 525812, 526991, 526992, 519997, 525807, 525813, 526990, 519984, 519985, 519986, 519996, 520002, 520003, 519987, 519988, 519989, 519990, 519998, 519999, 520000, 520001, 519991, 519993, 524179, 524180, 522822, 522827, 522829, 522830, 524398, 524400, 524402, 524404, 517972, 517973, 517975, 517976, 517977, 517978, 517979, 517980, 524397, 524401, 524405, 523972, 523973, 523974, 523976, 523977, 523978, 523979, 523980, 523981, 519699, 519701, 522823, 522824, 522825, 517932, 517933, 517934, 517935, 519702, 519703, 519704, 519705, 519706, 519708, 522819, 522820, 522812, 522813, 522814, 522821, 519259, 519260, 521283, 522815, 522816, 522817, 522818, 521282, 521285, 521286, 521280, 521281, 52128 …
What the firm is doing
On December 13, 2024, URGENT MEDICAL DEVICE CORRECTION (NOTIFICATION) letters were sent to customers. RECOMMENDATIONS: Product is not being removed and hospital inventory may continue to be used. It is recommended that users lower the pump flow level to P-2 and use imaging guidance when inserting, manipulating, or removing any guidewires, indwelling venous lines or devices to reduce the potential for interaction of the device tip with the pump inlet. If optical sensor damage occurs and Placement Signal Not Reliable (PSNR) alarm is displayed no additional actions are required. Hemodynamic support and Impella position are not affected and can be monitored as part of routine patient/pump management. In addition, calculated flow and suction monitoring are also unaffected when an optical sensor PSNR alarm is displayed. In the event of a pump stop, follow the displayed prompts of the Impella Stopped alarm. Damage to the guidewire, indwelling central venous line or other device involved in the unintended interaction should be evaluated, and users should assess if a new device is required. ACTIONS TO BE TAKEN BY CUSTOMER/USER: - Product is NOT being removed from the field and does not need to be returned. - Review, complete all fields, sign, and return the attached business response form (BRF) (refer to Attachment 2) to Abiomed6329@sedgwick.com. - Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). - If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. - Post a copy of this notice in a visible area for awareness. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting Program as per below instructions: - Complete and submit the report online: www.fda.gov/medwatch/report.htm or Regula
DistributionShow detailsHide
Domestic: Nationwide Distribution International: Canada
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0830-2025
- FDA device classification · PYXOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.4360The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Abiomed, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class I recalls
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a man…
- Pulmonary Valve Prosthesis Percutaneously Delivered
- Process control
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination