Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product... recall (Abiomed, Inc.)
Medical deviceClass IOngoing
Summary: Abiomed, Inc. is recalling Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.. Reason: Potential for thrombus formation during prolonged use of the introducer.
What is being recalled
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Why
Potential for thrombus formation during prolonged use of the introducer.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan. (states named: Florida, Illinois, Minnesota, New Jersey, New York, Virginia)
How to tell if yours is affected
Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2599-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | May 22, 2026 |
| Reported | July 1, 2026 |
| Company | Abiomed, Inc. |
| Company location | Danvers, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 units |
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