Abiomed, Inc. AB5000 Console Circulatory Support System Catalog Number: 0015-0000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AB5000 Console Circulatory Support System Catalog Number: 0015-0000
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 5261- 5317
Products Sold
Serial Numbers: 5261- 5317
Abiomed, Inc. is recalling AB5000 Console Circulatory Support System Catalog Number: 0015-0000 due to Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
Recommended Action
Per FDA guidance
Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026