Impella Heart Pump recallZ-0345-2020 · Abiomed, Inc. · initiated Sep 4, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.
FDA root cause category: Under Investigation by firm
What the company is doing
The affected device was retrieved from the only customer on 9/4/19. An Urgent Medical Device Recall notification letter dated 9/12/19 was sent to that customer as well.
Recall details
- Recall number
- Z-0345-2020
- Status
- Terminated
- Initiated by the company
- Sep 4, 2019
- Recalling firm
- Abiomed, Inc.
- Quantity
- 1
- Product code
- OZD
- FDA submissions
- P140003
- Distribution
- The product was distributed to GA
Product description
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Code information (models, lots, serial numbers)
UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Impella 0048-0024Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump2 recalls40 deaths296 reports
Product lines
Other devices under the same FDA submission
11 devices cleared under P140003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Impella 0048-0045Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump5 recalls1,269 deaths11,112 reports
- Impella 1000100Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump5 recalls848 deaths6,093 reports
- Impella 1000080Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump7 recalls987 deaths5,084 reports
- Impella 0042-0000-USAbiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump12 recalls120 deaths2,456 reports
- Impella 0042-0040-USAbiomed, Inc. · Temporary Non-Roller Type Right Heart Support Blood Pump8 recalls41 deaths1,305 reports
- Impella 0550-0008Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump4 recalls87 deaths1,005 reports
- Impella 0048-0032Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump3 recalls3 deaths42 reports
- Impella 0048-0003Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump6 deaths124 reports
- Impella 1000200Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump9 deaths84 reports
- Impella 0043-0003Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump1 recall7 reports
- Impella CP with SmartAssist 1000413Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump1 recall1 death5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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