Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
FDA Recall Z-2382-2010 · Posted 2010-09-07
Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeKFM
Date Initiated2010-07-05
Date Terminated2010-09-10
Product Quantity10 units
Reason for Recall
Pump may separate at the motor housing while device is explanted
Firm Action
ABIOMED issued the recall notification letter on July 5 , 2010 to the one affected customer (France) and requested that they segregate and return any unused pumps. The pumps in Canada were already used.
If you have any questions, contact +49 241 8860-0 or e-mail [email protected].
Root Cause
Process control
Distribution Pattern
International only: Canada and France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.