Key facts
| Recalling firm | Abiomed, Inc. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Automated Impella Controller (AIC); Product Code: 0042-0000-US; |
| Classification | Class I |
| Recall number | Z-2211-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What this classification means
FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Abiomed, Inc. and the affected product is described in FDA's record as: Automated Impella Controller (AIC); Product Code: 0042-0000-US;. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2211-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
What consumers should do
Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Automated Impella Controller (AIC); Product Code: 0042-0000-US; -- and the recall number Z-2211-2026. If it matches, stop using or distributing it and contact Abiomed, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Abiomed, Inc.’s FDA history
Argus HQ has recorded 8 total FDA actions tied to Abiomed, Inc.: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Has Abiomed, Inc. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 8 total FDA actions tied to Abiomed, Inc., including 8 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2211-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
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Related enforcement actions
Full FDA history for Abiomed, Inc.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class I Recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; by Abiomed, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-abiomed-inc-z-2211-2026
"FDA Recall Database: Class I Recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; by Abiomed, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-abiomed-inc-z-2211-2026.
Argus HQ Research. "FDA Recall Database: Class I Recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; by Abiomed, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-abiomed-inc-z-2211-2026.
@misc{argushq_argushq_ai_recall_fda_recall_abiomed_inc_z_2211_2026_2026,
title = {FDA Recall Database: Class I Recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; by Abiomed, Inc.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-abiomed-inc-z-2211-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗