FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
- Recall number
- Z-0345-2020
- Recalling firm
- Abiomed, Inc.
- Product
- lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
- Status
- Terminated
- Initiated
- 2019-09-04
- Posted
- not on file
- Terminated
- 2020-01-21
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 1
- Distribution
- The product was distributed to GA
- Lot, serial or model codes
- UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A
- 510(k) numbers
- not on file
- PMA numbers
- ["P140003"]
- Product code
- OZD
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28