Abiomed recalls lmpella CP with Smart Assist Model 0048-0003 due to incorrect programming that may cause pump migration and injury during cardiogenic shock support.
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.
Take action
Contact the company
📍Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575
“Abiomed Lmpella CP Smart Assist Pump Recall: Incorrect Programming Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67076-abiomed-lmpella-cp-smart-assist-pump-recall-incorrect-programming-risk. Based on FDA recall #Z-0345-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0345-2020%22&limit=1).
The FDA announced on 2019-09-04 that Abiomed, Inc. voluntarily recalled the lmpella CP with Smart Assist blood pump due to incorrect programming that disabled safety alarms and may have caused injury. The recall affects one unit distributed to Georgia.
How to tell if you have it
lmpella CP with Smart Assist, Model Number: 0048-0003
UPC: 00813502011371
Serial Number: 192148A
The hazard
The pump shipped with incorrect programming that would have immediately run at P9 for all selected P-levels instead of a ramp-up period. The positioning and suction alarms were disabled, and the pump may have migrated out of position, possibly causing injury.
Context
GovInfoNow's records show Abiomed, Inc. has had 28 other recalls since 2021-03-01. Recent Abiomed recalls include the 2026-08-12 Impella Optical Controller Recall for purge cassette recognition issues, the 2026-06-11 Impella CP Set Recall for introducer sheath leakage risk, and the 2026-05-22 Abiomed 14 Fr Introducer Kit Recall for blood clot risks. Other recent recalls of similar products include the BD Alaris Pump Infusion Sets Recall (2026-08-19), the MiniMed Flex Insulin Pump Recall (2026-08-20), and the ICU Medical Plum Solo IV Pump Recall (2026-04-29).
How to tell if you have this one
Check for the model number 0048-0003 on the pump. This product was sold with a unique identifier (UDI) starting with (01)00813502011371 and serial number 192148A.
Brand
Abiomed
Product
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Pump Model
Look for the model number 0048-0003 on the pump to confirm it is recalled.
Where it went and when
Where it was distributed
Distributed in Georgia.
Listed by the agency
Not listed
FDA distribution: “The product was distributed to GA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0345-2020 (September 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0345-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.