CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report
lmpella CP with Smart Assist recalled by Abiomed
Abiomed is recalling lmpella CP with Smart Assist, distributed in Georgia. The recall was initiated on 4 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0345-2020
- FDA event ID
- 84025
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2019
- FDA classified
- 7 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 4 Sep 2019 | Recall initiated by company | |
| 7 Nov 2019 | Classified by FDA | +64 days |
| 13 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Where it was distributed
The product was distributed to GA
Questions about this recall
Why was it 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.
Which lots are affected?
UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A
Where was it sold?
The product was distributed to GA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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