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U.S. Department of Health and Human Services

Class 1 Device Recall System 98/98XT, CS100/CS100i, CS300 IntraAortic Balloon Pump

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 Class 1 Recall
System 98/98XT, CS100/CS100i, CS300 IntraAortic Balloon Pump
see related information
Date Posted June 13, 2011
Recall Status1 Terminated on October 25, 2012
Recall Number Z-2414-2011
Recall Event ID 58661
Premarket Notification
510(K) Numbers
K031636  K063525  K965236 
Product Classification Incubator, Neonatal - Product Code FMZ
Product Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.
Code Information System 98 - Part Numbers 0998-00-0446-xx, 0998-UC-0446-xx; System 98XT - Part numbers 0998-00-0479-xx, 0998-UC-0479-xx ; CS100i- Part numbers 0998-UC-0446Hxx, 0998-UC-0479Hxx; CS100 - Part numbers 0998-00-3013-xx, 0998-UC-3013-xx; CS300 - Part numbers 0998-00-3023-xx, 0998-UC-3023-xx
Recalling Firm/
Manufacturer
Maquet Datascope Corp - Cardiac Assist Division
1300 MacArthur Blvd.
Mahwah, New Jersey 07430-2052
For Additional Information Contact Ms. Susan E. Mandy
201-995-8782
Manufacturer Reason
for Recall
Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.
FDA Determined
Cause 2
DESIGN: Device Design
Action Maquet sent an Urgent Product Field Correction letter dated March 16, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to note the WARNING in the IABP Operating Instruction. Customers were advised to refer to the IAB Instructions for Use, Section D (Manually inflating and Deflating a Catheter). Section D of the IAB instruction for Use reiterates that an IAB should not remain inactive for more than 30 minutes and also provides detailed instruction on how to keep an IAB active during IABP failure. Customers were advised that their Service Representatiave would arrange to replace their supply which would contain a new fan assembly. Upon completion of the power supply replacement, customers were asked to sign a service repair order to verify satisfactory completion of the work. For technical questions contact Technical Support Department at 1-800-777-4222 and press 4. For scheduling a service visit by a Field Service Representatiave, contact the firm's US Call Center at 1-800-777-4222 and press 3. Maquet issued a press release on June 6, 2011 advising consumers of the issue and that their recall was considered a class one.
Quantity in Commerce 885 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMZ and Original Applicant = DATASCOPE CORP.
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