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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 May 13, 2016
Create Date June 08, 2016
Recall Status1 Terminated 3 on March 22, 2019
Recall Number Z-1935-2016
Recall Event ID 74225
510(K)Number K120868  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿

MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿

MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿

MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA
Code Information (PN 0684-00-0294-01U) (PN 0684-00-0294-02U) (PN 0684-00-0295-01U) (PN 0684-00-0295-02U) (PN 0684-00-0296-01U)
Recalling Firm/
Datascope Corporation
15 Law Dr
Fairfield NJ 07004-0011
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce 31,030 units (US); 15,604 units (OUS)
Distribution Worldwide Distribution.
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., CARDIAC ASSIST DIVISION