Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP
Potential for thrombus formation during prolonged use of the introducer.
- Agency
- FDA Device
- Recall date
- May 22, 2026
- Status
- Ongoing
- Company
- Abiomed, Inc.
1. What product was recalled?
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Quantity: 3 units
Code or lot text: Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.
- LOT
- Batch Number: 2038639.
- LOT
- GTIN: 00813502012996
- LOT
- Impella Set Product Code: 1000434
- LOT
- Serial Numbers: N/A. Introducer Product Code: 1000434
- RECALL-NUMBER
- Z-2599-2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Quantity: 7 units
Code or lot text: Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
- LOT
- Batch Number: 2041530.
- LOT
- GTIN: 813502013467
- LOT
- Impella Set Product Code: 1000542
- LOT
- Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542
- RECALL-NUMBER
- Z-2602-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Potential for thrombus formation during prolonged use of the introducer.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Florida: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Illinois: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Minnesota: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- New Jersey: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- New York: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Virginia: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
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10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.