Quick Facts at a Glance
- Recall Date
- May 22, 2026
- Hazard Level
- HIGH
- Brand
- Abiomed
- Geographic Scope
- 1 states
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
- Model numbers
- 1. Impella Set Product Code: 1000413, GTIN: 00813502013566, Serial numbers: 649727, 649728, 649729, 649730, 649731, 654349 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 22, 2026
Reported by FDA DEVICE
July 1, 2026
RecallRadar source check
July 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for thrombus formation during prolonged use of the introducer.
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
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Full Description
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.. Reason: Potential for thrombus formation during prolonged use of the introducer.. Classification: Class I. Quantity: 168 units. Distribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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