Reported Sep 30, 2026 · Ongoing · Updated Oct 24, 2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella…
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
7 of 7 products
| Model / number | Product as published |
|---|---|
0042-0000-CA. | Impella Controller, Packaged, CA |
0042-0000-EU. | Impella Controller, Packaged, EU |
0042-0000-UK. | Impella Controller, Packaged, UK |
0042-0000-US. | Impella Controller, Packaged, US |
0042-0010-EU. | Impella Optical Controller, Packaged, EU |
0042-0010-US. | Impella Optical Controller, Packaged, US |
0042-0040-US. | Optical, AIC, Impella Connect, Pkgd, US |
- Lot codes and dates
- 1
- Product Code0042-0000-CA
- GTIN00813502011272
- Serial NumberIC2687. 2
- Product Code0042-0000-EU
- GTIN00813502011289
- Serial Numbers
343 of 343 codes
IC3875IC2380IC2331IC1721IC1593IC1587IC4911IC4231IC4232IC6844IC2221IC4628IC6474IC4502IC1398IC4055IC3816IC6810IC6812IC6449IC6469IC6441IC6443IC6440IC6436IC6437IC6439IC6272IC6149IC6081IC5681IC5682IC5517IC5177IC5169IC5086IC4892IC4852IC4848IC4875IC4851IC4869IC4823IC4824IC4821IC4822IC4845IC4840IC4819IC4820IC4817IC4818IC4815IC4816IC4796IC4797IC4793IC4795IC4792IC4794
- Product Code0042-0000-UK
- GTIN00813502011296
- Serial Numbers
IC1494IC3785IC3784. 4
- Product Code0042-0000-US
- GTIN00813502010022
- Serial Numbers
2,690 of 2,690 codes
IC7027IC7030IC7032IC6931IC6930IC6932IC6929IC6928IC6923IC6919IC6920IC6921IC6922IC6898IC6897IC6917IC6916IC6889IC6894IC6895IC6893IC6901IC6909IC6911IC6910IC6912IC6908IC6913IC6896IC6899IC6900IC6842IC6840IC6836IC6829IC6831IC6832IC6811IC6774IC6864IC6830IC6801IC6800IC6798IC6799IC6847IC6771IC6772IC6850IC6851IC6852IC6854IC6822IC6820IC6819IC6818IC6767IC6754IC6743IC6729
- Product Code0042-0010-EU
- GTIN00813502010961
- Serial Numbers
266 of 266 codes
IC6118IC6119IC5129IC5042IC5919IC5282IC6263IC6261IC5580IC5592IC5038IC7156IC6779IC6776IC6462IC6418IC6379IC6416IC6417IC6383IC6384IC6377IC6378IC6344IC6305IC6336IC6337IC6304IC6303IC6342IC6343IC6302IC6297IC6298IC6299IC6282IC6283IC6278IC6279IC6277IC6260IC6259IC6257IC6258IC6235IC6256IC6070IC6231IC6232IC6234IC6175IC6226IC6168IC6169IC6166IC6167IC6122IC6123IC6121IC6174
- Product Code0042-0010-US
- GTIN00813502010985
- Serial Numbers
IC7251IC7037IC7023IC7021IC6996IC6998IC6999IC6975IC6997IC6974IC6972IC6963IC6964IC6959IC6958IC6957IC5971IC5970. 7
- Product Code0042-0040-US
- GTIN00813502011401
- Serial NumbersIC7186
- Amount recalled
- 3,322 units
Where it was sold
- Nationwide
Why it was recalled
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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