FDA Devices Verify with FDA Devices → Critical Class I Ongoing

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Con

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 29, 2025. Severity: Critical. Recall number: Z-0136-2026.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0136-2026) 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.

Q: 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.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 6, 2026

Reported: October 29, 2025 Initiated: September 16, 2025 #Z-0136-2026 9,177 total distributed units (754 pending correction) units

Abiomed, Inc. issued this FDA Devices recall on October 29, 2025. Classified as Critical severity (Class I). Approximately 9,177 total distributed units (754 pending correction) units are affected. The recall was issued because: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0136-2026) was formally reported on October 29, 2025, with the manufacturer initiating the action on September 16, 2025. 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 indicate 9,177 total distributed units (754 pending correction) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexi…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Critical

Units Affected

9,177 total distributed units (754 pending correction)

Related Recalls

6 from same agency

Product Description

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.

Reason for Recall

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Details

Recalling Firm: Abiomed, Inc.
Units Affected: 9,177 total distributed units (754 pending correction)
Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland.
Location: Danvers, MA

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Ongoing
Recall number	Z-0136-2026
Date reported	October 29, 2025
Date initiated	September 16, 2025
Recalling firm	Abiomed, Inc.
Units affected	9,177 total distributed units (754 pending correction)
Distribution	Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pak…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

9,177 total distributed units (754 pending correction) units affected — million-unit bracket.

Regional (<10K units) —

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 29, 2025. Severity: Critical. Recall number: Z-0136-2026.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0136-2026) 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.

Recall Guides

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Understanding Recall Severity Classes

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Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

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)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product 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.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-06 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).