Z-0345-2020Class II

lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During...

Name: Z-0345-2020 lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During...
Creator: Abiomed, Inc.
Published: 2019-09-04
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2019-09-04 / Terminated / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI on 2019-09-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0345-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-04
Posted: 2019-11-07
Terminated: 2020-01-21
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
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 1
Distribution: The product was distributed to GA
Product codes and lots: UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0345-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0345-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)