Date Initiated by Firm |
December 23, 2016 |
Create Date |
March 02, 2017 |
Recall Status1 |
Terminated 3 on March 01, 2019 |
Recall Number |
Z-1386-2017 |
Recall Event ID |
76052 |
510(K)Number |
K112372 K151254
|
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
Product |
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097
Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
|
Code Information |
part number 0146-00-0097 |
Recalling Firm/ Manufacturer |
Maquet Datascope Corp - Cardiac Assist Division 1300 Macarthur Blvd Mahwah NJ 07430-2052
|
For Additional Information Contact |
Karen LeFevere 973-244-6138
|
Manufacturer Reason for Recall |
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
|
FDA Determined Cause 2 |
Device Design |
Action |
Maquet contacted their customers via letter on 12/23/16 and additional customers identified were notified on 1/10/17 and issued a recall letter/return response form. The letter identified the affected product problem and actions to be taken. Customers were instructed to complete and return the response form via fax to 1-973-629-1518 or email to cardiosavebattery@getinge.com |
Quantity in Commerce |
8000 |
Distribution |
Worldwide Distribution - US Nationwide |
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 = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC 510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.
|