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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Inc.

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  Class 2 Device Recall Maquet Inc. see related information
Date Initiated by Firm April 12, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 on January 28, 2020
Recall Number Z-2164-2017
Recall Event ID 76942
510(K)Number K133074  
Product Classification System, Balloon, Intra-Aortic And Control - Product Code DSP
Product SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
Code Information 300004515,  3000043376 3000040272 3000038372  added lot numbers:  3000043374 and 3000045513
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information Contact
973-244-6100
Manufacturer Reason
for Recall		 Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.
FDA Determined
Cause 2		 Device Design
Action Getinge notified their customers with a recall letter/return response form via Fed Ex on 4/12/2017. Getinge notified their customers again through an expansion on 10/16/2017.
Quantity in Commerce 996 UNITS
Distribution 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 = DATASCOPE CORP.
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