FDA Devices Verify with FDA Devices → Critical Class I Ongoing

Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist Updated February 2024 (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 21, 2024. Severity: Critical. Recall number: Z-0980-2024.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI..

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

Check the product description and recall number (Z-0980-2024) 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: February 21, 2024 Initiated: December 27, 2023 #Z-0980-2024 91,914 (65,857 US; 26,075 OUS) units

Abiomed, Inc. issued this FDA Devices recall on February 21, 2024. Classified as Critical severity (Class I). Approximately 91,914 (65,857 US; 26,075 OUS) units are affected. The recall was issued because: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the lef…. 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-0980-2024) was formally reported on February 21, 2024, with the manufacturer initiating the action on December 27, 2023. 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 91,914 (65,857 US; 26,075 OUS) 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: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.. 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 2 years 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

91,914 (65,857 US; 26,075 OUS)

Related Recalls

6 from same agency

Product Description

Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC

Reason for Recall

IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

Details

Recalling Firm: Abiomed, Inc.
Units Affected: 91,914 (65,857 US; 26,075 OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
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-0980-2024
Date reported	February 21, 2024
Date initiated	December 27, 2023
Recalling firm	Abiomed, Inc.
Units affected	91,914 (65,857 US; 26,075 OUS)
Distribution	Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.

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

Scale of Impact

91,914 (65,857 US; 26,075 OUS) 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? ▼

IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 21, 2024. Severity: Critical. Recall number: Z-0980-2024.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI..

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

Check the product description and recall number (Z-0980-2024) 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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Product Injury 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).