Date Initiated by Firm | March 21, 2014 |
Date Posted | May 21, 2014 |
Recall Status1 |
Terminated 3 on March 20, 2018 |
Recall Number | Z-1523-2014 |
Recall Event ID |
67815 |
510(K)Number | K031636 K063525 K965236 |
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
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Product | Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures. |
Code Information |
IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx |
Recalling Firm/ Manufacturer |
Maquet Datascope Corp - Cardiac Assist Division 1300 MacArthur Blvd. Mahwah NJ 07430-2052
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For Additional Information Contact | Ms. Karen LeFevere 973-709-7652 |
Manufacturer Reason for Recall | Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Maquet Inc. sent an Urgent Medical Device Field Correction letter dated March 21, 2014, to all affected customers. The letter identified the affected product, problem, and actions to be taken.. Customers were instructed that their Service Representatiave would contact them to schedule the replacement of the fan assembly at no cost to the customer. Upon completion customers were requested to sign a service repair order to verify satisfactory completion of the work. Customers with questions within Puerto Rico, were instructed to contact Technical Support in Mexico at +52-55-9000-8970, ext 104.
For questions regarding this recall call 973-709-7652.
A field correction letter was sent out on April 15, 2014 to additional consignees that did not receive the March 15, 2014 letter.
Maquet issued press on May 9, 2014. |
Quantity in Commerce | 11,881 units (US 5183 and OUS 6698) |
Distribution | Worldwide Distribution - USA (nationwide) and approximately 104 countries. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DSP
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