CLASS I ONGOING Device recall · Reported 3 Jun 2026 · FDA Enforcement Report
Automated Impella Controller (AIC) recalled by Abiomed
Abiomed is recalling Automated Impella Controller (AIC), distributed nationwide in the US. The recall was initiated on 20 Apr 2026 and the FDA has classified it as Class I.
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-2211-2026
- FDA event ID
- 98770
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Apr 2026
- FDA classified
- 22 May 2026
- Reported
- 3 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 20 Apr 2026 | Recall initiated by company | |
| 22 May 2026 | Classified by FDA | +32 days |
| 3 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
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
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom;
Nationwide CaliforniaConnecticutFloridaLouisianaMassachusettsMichiganMissouriMississippiNorth DakotaNew YorkOhioPennsylvaniaTexasWyoming
Questions about this recall
Why was it recalled?
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
Which lots are affected?
Product Code: 0042-0000-US; UDI-DI: 00813502010022; Serial Numbers: IC2449, IC2451, IC2452, IC2453, IC2459, IC2460, IC1096, IC1142, IC1202, IC1203, IC1224, IC1231, IC1238, IC1284, IC1285, IC1390, IC1545, IC1577, IC1665, IC1708, IC1741, IC1852, IC1853, IC2029, IC2071, IC2154, IC2277, IC2278, IC2314, IC2315, IC2368, IC2369, IC2370, IC2442, IC2443, IC2444, IC2461, IC2471, IC2476, IC2477, IC2478, IC2479, IC2575, IC2989, IC3127, IC3128, IC3129, IC3130, IC3166, IC3167, IC3213, IC3223, IC3306, IC3307, IC3308, IC3309, IC3342, IC3398, IC3475, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3674, IC3675, IC3719, IC3720, IC3776, IC3812, IC3887, IC3888, IC4045, IC4060, IC1301, IC1544, IC1572, IC2686, IC2687, IC2848, IC3174, IC3269, IC3272, IC3277, IC3278, IC3281, IC3282, IC3284, IC3294, IC3783;
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom;
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
More recalls from Abiomed
All 74| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | Impella Optical Controller, Automated Impella Controller recalled | Abiomed | Device Malfunction | Nationwide |
| Device | CLASS I | Impella Optical Controller with the below product recalled by Abiomed | Abiomed | Device Malfunction | Nationwide |
| Device | CLASS I | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Device Malfunction | Nationwide |
| Device | CLASS I | Introducer Kit, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |