Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported June 3, 2026
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented t…
The recall
Abiomed, Inc. issued this critical-severity FDA Devices recall — A retrospective review identified that there are AIC units requiring specific hardware updates to address pot….
- Critical
- severity level
- 91 units
- affected scope
- Class I
- classification
- June 3, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2211-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2211-2026) was formally reported on June 3, 2026, with the manufacturer initiating the action on April 20, 2026. It is classified under Critical severity (Class I), with a current status of Ongoing. Abiomed, Inc. is listed as the recalling firm, operating out of Danvers, MA. Federal records list the affected scope as 91 units.
The documented reason for this 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; ther… Distribution data in the federal record shows the product reached: 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;. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices and 1 from Abiomed, Inc. — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Affected scope
91 units
Related Recalls
6
6 from same agency
Product description
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2211-2026 |
| Date reported | June 3, 2026 |
| Date initiated | April 20, 2026 |
| Recalling firm | Abiomed, Inc. |
| Firm location | Danvers, MA |
| Affected scope | 91 units |
| Distribution | 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; |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2211-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Automated Impella Controller (AIC); Product Code: 0042-0000-US;. Recalled by Abiomed, Inc.. Units affected: 91 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2026. Severity: Critical. Recall number: Z-2211-2026.
Where was the recalled product distributed? ▼
Distribution: 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;.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2211-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 3, 2026.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.