SeriousFDAOngoing
Can cause serious illness or death. Do not eat it.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Check your package for
Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
- Why
- Potential for thrombus formation during prolonged use of the introducer.
- Distributed
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Company
- Abiomed, Inc.
- Announced
- Recall began