The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0345-2020·Announced 2019-11-13

Abiomed lmpella CP Pump Recalled for Incorrect Programming and Disabled Alarms

Abiomed is recalling one lmpella CP pump with Smart Assist due to incorrect programming that disabled safety alarms and altered pump operation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text states the pump 'possibly caused injury' and the FDA classified the recall as Class II. Per the rubric, FDA Class II recalls with injury reports are classified as Severe.

Plain-English summary

Abiomed, Inc. is recalling one unit of the lmpella CP with Smart Assist, Model Number 0048-0003. This left heart support blood pump is intended for use during cardiogenic shock and high-risk PCI. The specific unit involved has Serial Number 192148A and UDI (01)00813502011371(10)1430951(17)210331(21)192148A.

The recall was initiated because the pump shipped with incorrect programming, specifically the initial production working version of the program. This error caused the pump to run immediately at P9 for all selected P-levels, bypassing the standard 10-second ramp-up period. Additionally, the positioning and suction alarms were disabled. The FDA notes that the pump may have migrated out of position and possibly caused injury.

The product was distributed to Georgia. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients who have used this specific device should contact Abiomed, Inc. for further instructions.

The recalled product

Product
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 1 state:

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