Abiomed, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0345-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 4, 2019

Date Posted: November 13, 2019

Recall Number: Z-0345-2020

Event ID: 84025

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.

Status: Terminated

Product Quantity: 1

Code Information:

UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A

Distribution Pattern:

The product was distributed to GA

Voluntary or Mandated:

Voluntary: Firm initiated