SeriousFDAOngoing
Can cause serious illness or death. Do not eat it.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Check your package for
Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
- 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