Navigation Links
Voluntary Worldwide Field Correction Issued for the S98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps
Date:6/6/2011

MAHWAH, N.J., June 6, 2011 /PRNewswire/ -- In March 2011, Datascope Corp/Maquet initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT (Part numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 ( Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names.  Customers who have 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT, CS100/CS100i and CS300 IABP brand names which are being recalled may schedule a visit by a Service Representative by contacting the US Call Center at 1-800-777-4222, Press 3.

A total of 840 US customer IABPs and 453 international customer IABPs are affected by this field correction. Between May 2008 and December 2010 specific System 98/98XT, CS100/CS100i and CS300 IABPs were manufactured with an affected power supply, or may have received an affected power supply during an upgrade/service of the IABP in the field.  In specific units, the fan assembly of the power supply could potentially contain a misshapen retaining ring.  This retaining ring could disengage within the fan, causing the fan blade assembly to stop rotating.  Consequently, the power supply would detect an overheating event, and shut down without visual or audible alarms.  The data to date indicates that there is a very small likelihood for an IABP to contain a misshapen retaining ring.  This device failure may result in unanticipated interruption of counterpulsation therapy.

The U.S. Food and Drug Administration ("FDA") has classified this action as a Class 1 recall. FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Datascope Corp/Maquet initiated the field correction in March 2011 and at that time notified all customers that may have an IABP affected by this field correction.  The corrective action associated with this field correction is to provide an upgraded power supply to all IABPs containing an affected power supply.  A Service Representative will conduct the upgrade and document this corrective action during a visit to the customer.  To date, 55% of US customer units have been completed and every effort is being made to complete all affected domestic IABPs as soon as possible.

For additional information regarding this field correction, please contact the Technical Support Department at 1-800-777-4222 and Press 4 (Monday through Friday from 9:00 am-5:30 pm EDT).  For scheduling a service visit by a Field Service Representative, please contact our US Call Center at 1-800-777-4222 and Press 3 (Monday though Friday from 8:30 am 5:30 pm EDT). To contact the US Call Center after business hours, please contact 1-800-777-4222, and Press 0.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.  


'/>"/>
SOURCE MAQUET Cardiovascular
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. American Regent Expands Voluntary Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials
2. McNeil Consumer Healthcare Announces Voluntary Recall of Certain Lots of TYLENOL(R) Arthritis Pain 100 Count with EZ-OPEN CAP
3. deCODE genetics, Inc. Files Voluntary Chapter 11 Petition to Facilitate Sale of Assets
4. McNeil Consumer Healthcare Announces a Voluntary Nationwide Recall of All Lots of TYLENOL(R) Arthritis Pain 100 Count With EZ-OPEN CAP
5. Simcere Pharmaceutical Group Announces Jiangsu Yanshens Voluntary Suspension of Production
6. Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®
7. Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN® and PROCRIT® (Epoetin alfa)
8. McNeil Consumer Healthcare Announces Voluntary Recall of One Product Lot of TYLENOL® 8 Hour Caplets 50 Count Sold in the United States and Puerto Rico
9. Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h
10. American Regent Initiates Voluntary Recall of Magnesium Sulfate Injection, USP 50% (25 grams/50 mL), 50mL Single Dose Vial Lot # 0491
11. Poniard Pharmaceuticals Announces Plan for Voluntary Prepayment of Term Loan and Transfer to Nasdaq Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016 Dublin ... addition of the " Global Markets for Spectroscopy ... This report focuses on the ... review, including its applications in various applications. The report ... includes three main industries: pharmaceutical and biotechnology, food and ...
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016 /PRNewswire/ ... pulmonary function testing company, is now able to perform sophisticated lung ... ndd Medical Technologies , Inc. Patients are ... labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients like ... any needed testing done in the comfort of her own home. ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe ... from the David Geffen School of Medicine at UCLA. He trained in Internal Medicine ... his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
(Date:6/24/2016)... ... 24, 2016 , ... Dr. Amanda Cheng, an orthodontist ... has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be used ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... ... Haute Living, is proud to recognize Dr. Barry M. Weintraub as a prominent ... “the most beautiful women in the world, and the most handsome men, look ...
Breaking Medicine News(10 mins):