Device product
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Z-2599-2026
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 99002
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2599-2026
Official wording
Reason: Potential for thrombus formation during prolonged use of the introducer.
Code information: Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.
Distribution pattern: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Derived failure modes
-
Unknown
Potential for thrombus formation during prolonged use of the introducer.