Z-2382-2010

Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for...

Name: Z-2382-2010 Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for...
Creator: Abiomed, Inc.
Published: 2010-07-05
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2010-07-05 / Terminated / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control... on 2010-07-05. The reason FDA records is "Pump may separate at the motor housing while device is explanted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2382-2010
Status: Terminated
Initiated: 2010-07-05
Posted: 2010-09-07
Terminated: 2010-09-10
Recalling firm: Abiomed, Inc.
Product: 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
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: Pump may separate at the motor housing while device is explanted
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 10 units
Distribution: International only: Canada and France
Product codes and lots: Serial numbers: 45921,45922,45923,45924

Product code KFM

K083111Class IIImpella 5.0 Catheter FamilyAbiomed, Inc. / cleared 2009-04-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)