Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brand
- Abiomed
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abiomed
- Product type
- Purge Cassette
- Model numbers
- 0043-0003, 004334, 0043-0002, 004413, 005040, 0046-0011, 0048-0002, 0048-0002-BR +8 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 18, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Increased risk of purge leaks with Generation 1 purge cassettes.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Purge cassettes are components used with Impella left ventricular assist devices in high-acuity cardiovascular care. They are deployed in hospital settings and require sterility and precise function.
Why This Is Dangerous
Generation 1 purge cassettes may leak purge fluid, potentially compromising device performance and patient safety during support.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinicians must halt use of affected cassettes and follow recall procedures to avoid potential device malfunction during support.
Practical Guidance
How to identify if yours is affected
- Review product codes listed in the recall notice against your inventory.
- Check GTINs where available for the affected Purge Cassette units.
- Inspect for any signs of purge leakage if the device is in use per clinical protocols.
Where to find product info
Refer to the FDA enforcement report Z-1589-2026 and Abiomed recall communications for detailed identifiers and replacement guidance.
What timeline to expect
Remedy timelines vary; plans for refunds or replacements will be provided by Abiomed and health systems.
If the manufacturer is unresponsive
- Document all requests and dates.
- Escalate through hospital supply chains or regulatory channels if Abiomed is slow to respond.
How to prevent similar issues
- Verify device compatibility and purity of purge cassette components before deployment.
- Monitor for recall updates and confirm supplier communications prior to use.
Documentation advice
Keep copies of recall notices, GTINs, product codes, batch numbers, and all correspondence with Abiomed.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 33,107 units recalled worldwide
- Generation 1 purge cassette leaks identified as the hazard
- Class I recall with worldwide distribution
- No injuries or incidents reported to date
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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