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U.S. Department of Health and Human Services

Class 2 Device Recall Impella 5.0 Circulatory Support System

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  Class 2 Device Recall Impella 5.0 Circulatory Support System see related information
Date Initiated by Firm July 05, 2010
Date Posted September 07, 2010
Recall Status1 Terminated 3 on September 10, 2010
Recall Number Z-2382-2010
Recall Event ID 56315
510(K)Number K083111  
Product Classification pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
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
Code Information Serial numbers: 45921,45922,45923,45924
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923
For Additional Information Contact SAME
978-777-5410 Ext. 225
Manufacturer Reason
for Recall		 Pump may separate at the motor housing while device is explanted
FDA Determined
Cause 2		 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 europe@abiomed.com.
Quantity in Commerce 10 units
Distribution International only: Canada and France
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KFM and Original Applicant = ABIOMED, INC.
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