Class I Recall

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller

Summary

The FDA issued a Class I for Automated Impella Controller (AIC), labeled as the following with corresponding by Abiomed, Inc.. Reason: Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impell.

Details

Source

Device Recall

External ID

Z-1591-2026

Action Date

2026-04-08

Status

Ongoing

Product Description

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

Lot/Code Info: All products below with software version 8.2.2 through 8.5 are affected. 1. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416. 2. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581. 3. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312. 4. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140. 5. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683. 6. Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440. 7. Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894. 8. Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425. 9. Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.

Quantity Affected: 62 units

Reason for Recall

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Distribution

International distribution in the country of Australia, Canada, France, Germany, Kuwait.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-02-16

Company

Abiomed, Inc.

Danvers, MA

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 252 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Abiomed, Inc. have FDA actions?

Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1591-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29