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U.S. Department of Health and Human Services

Class 2 Device Recall IntraAortic Balloon Catheter Mega 7.5FR 30cc

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  Class 2 Device Recall IntraAortic Balloon Catheter Mega 7.5FR 30cc see related information
Date Initiated by Firm February 21, 2018
Date Posted April 16, 2018
Recall Status1 Terminated 3 on March 18, 2020
Recall Number Z-1384-2018
Recall Event ID 79646
510(K)Number K120868  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Intra-Aortic Balloon Catheter Mega 7.5FR 30cc

Product Usage:
The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Code Information 0684 00 0294 01U and 0684 00 0294 02U
Recalling Firm/
Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information Contact Marylou Insinga
Manufacturer Reason
for Recall
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
FDA Determined
Cause 2
Error in labeling
Action Maquet/Getinge issued a recall letter on February 21, 2018 to affected customers, via FEDEX with confirmation of delivery, to notify them of the fact that the IFU is missing the Contraindications section and to provide the missing information. Affected customers are instructed to examine their inventory immediately to determine if they have affected product. An Addendum to the Mega IAB Catheter IFU, containing the Contraindications, is provided as an attachment in the recall letter. It is suggested that affected customers post copies of the Addendum near all affected lot numbers of Mega IAB Catheters. Customers are provided with Maquet/Getinge contact information should their facility require a full copy of the correct Mega IAB Catheter IFU. Lastly, affected customers are instructed to complete and sign a response form, acknowledging that they have received the notification, and return the form to Maquet/Getinge.
Quantity in Commerce 655
Distribution US Nationwide 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