CriticalClass IOngoing

FDA Devices recall · Reported April 8, 2026

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product C

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 8, 2026. Severity: Critical. Recall number: Z-1589-2026.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution..

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

Check the product description and recall number (Z-1589-2026) 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.

Increased risk of purge leaks with Generation 1 purge cassettes.

Recall #: Z-1589-2026
Affected scope: 33,107 units
Initiated: February 18, 2026

Reviewed by PlainRecalls Editorial, Product Recalls Editorial Team

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The recall

Abiomed, Inc. issued this critical-severity FDA Devices recall — Increased risk of purge leaks with Generation 1 purge cassettes..

Critical
severity level: 33K units
affected scope: Class I
classification: April 8, 2026
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1589-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1589-2026) was formally reported on April 8, 2026, with the manufacturer initiating the action on February 18, 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 33,107 units.

The documented reason for this recall is: Increased risk of purge leaks with Generation 1 purge cassettes. Distribution data in the federal record shows the product reached: Worldwide distribution.. 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.

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.

Severity

Critical

Affected scope

33,107 units

Related Recalls

6 from same agency

Product description

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).

Reason for recall

Increased risk of purge leaks with Generation 1 purge cassettes.

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-1589-2026
Date reported	April 8, 2026
Date initiated	February 18, 2026
Recalling firm	Abiomed, Inc.
Firm location	Danvers, MA
Affected scope	33,107 units
Distribution	Worldwide distribution.

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

Scale of Impact

33,107 units units affected — limited or regional distribution scale.

Regional (<10K units) —

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) —

Massive (≥1M units) —

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.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1589-2026) 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? ▼

Why was this product recalled? ▼

Increased risk of purge leaks with Generation 1 purge cassettes.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 8, 2026. Severity: Critical. Recall number: Z-1589-2026.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution..

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

Check the product description and recall number (Z-1589-2026) 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 April 8, 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.