Purge Cassette
Abiomed is a leading manufacturer of medical devices and equipment, specializing in cardiovascular and vascular products. Their products include heart valves, catheters, and other critical medical devices.
Lower-risk recall
Increased risk of purge leaks with Generation 1 purge cassettes.
Contact the company
What happened, in plain English
Abiomed is a leading manufacturer of medical devices and equipment, specializing in cardiovascular and vascular products. Their products include heart valves, catheters, and other critical medical devices. Read more at govinfonow.com/recall/49960-abiomed.
Source Summary by GovInfoNow · govinfonow.com/recall/49960-abiomed · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1589-2026
Cite this page
“Purge Cassette.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49960-abiomed. Based on FDA recall #Z-1589-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1589-2026%22&limit=1).
Why it’s dangerous
Abiomed is a reputable medical device manufacturer with a strong track record of safety and quality. Their products are widely used in healthcare settings and have been extensively tested for safety and efficacy.
Who’s affected
All users of Abiomed products
How to tell if you have this one
Check for the latest product specifications and safety guidelines from Abiomed's official website. Ensure that the product is certified by relevant regulatory bodies such as the FDA.
- Brand
Abiomed- Product
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below- Category
Medical device
What to do — step by step
1
Verify the product's certification status with the FDA or other relevant regulatory bodies.
2
Review the product's safety data sheet (SDS) for any potential hazards.
3
Ensure that the product is used within the recommended parameters and guidelines.
How this recall unfolded
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1589-2026 (February 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1589-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.