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Terminated

lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI

FDA Recall Z-0345-2020 · Posted None

Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeOZD
Date Initiated2019-09-04
Date Terminated2020-01-21
Product Quantity1

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

The product was distributed to GA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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