Device product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Z-2602-2026
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 99002
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 7 units
- Official record key
device-enforcement:Z-2602-2026
Official wording
Reason: Potential for thrombus formation during prolonged use of the introducer.
Code information: Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
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.