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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 December 16, 2015
Create Date March 25, 2016
Recall Status1 Terminated 3 on June 01, 2018
Recall Number Z-1248-2016
Recall Event ID 72890
510(K)Number K112372  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Hybrid and rescue IABP
Code Information Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
Recalling Firm/
Manufacturer		 Maquet Datascope Corp - Cardiac Assist Division
1300 MacArthur Blvd.
Mahwah NJ 07430-2052
For Additional Information Contact Mrs. Karen LeFevre
973-244-6138
Manufacturer Reason
for Recall		 Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
FDA Determined
Cause 2		 Other
Action Maquet sent an "Urgent - Medical Device Field Correction Notice and Response form dated December 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed of the issues and provided corrective actions. Customers are asked to completed the attached response form in order to return to 1-973-629-1518, or via email to cardiosavescroll@maquet.com. Questions can be directed 1-800-777-4222, option 3, Monday through Friday 8 am-6 pm. EST.
Quantity in Commerce 1243 units US; 1107 units OUS
Distribution Worldwide Distribution- Nationwide Distribution including Puerto Rico.
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
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