Device product
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Z-2600-2026
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 99002
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 17 units
- Official record key
device-enforcement:Z-2600-2026
Official wording
Reason: Potential for thrombus formation during prolonged use of the introducer.
Code information: Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
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.