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:6/11/2017)... -- Eli Lilly and Company (NYSE: LLY ) announced ... galcanezumab, an investigational treatment for the prevention of episodic ... secondary endpoints for galcanezumab compared to placebo at both ... and REGAIN) will be presented today at the American ... Boston . "The detailed Phase ...
(Date:6/9/2017)... ALTO, Calif. , June 9, 2017 ... device company focused on the design, manufacture, sale and ... the market on the progress of its commercial roll-out ... is now available in more than one hundred (100) ... AeroForm offers a needle-free alternative for ...
(Date:6/8/2017)... -- Less than a month ago, amateur hackers executed an ... hospital networks, in over 150 countries. The ... online extortion attempts ever recorded. With the increasing complexity ... that providers understand where the risks lie, and how ... many other very real cyber threats.  ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... Military Connection friend and veteran ... the JFK Virgin Atlantic lounge. , Bensko is no stranger to the plight ... Bensko dedicated her life to supporting our wounded veterans. A world-class photographer, her riveting ...
(Date:6/23/2017)... ... June 23, 2017 , ... Georgia State University will host ... , The two-day conference is focused on advancing scientific knowledge about the aggressive ... and eliminating racial breast cancer-related disparities. The conference theme is “Illuminating Actionable Biology.” ...
(Date:6/23/2017)... ... , ... American Farmer, will feature Chr. Hansen, Inc (CHR Hansen) in an ... 2017. American Farmer airs Tuesdays at 8:30aET on RFD-TV. Check your local listings for ... Denmark in 1874 after a groundbreaking discovery of how to industrialize enzymes. Rooted in ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... ... services and personal financial planning to families and business owners in North Central ... organization to help provide services to differently abled residents in the region. , ...
(Date:6/22/2017)... , ... June 22, 2017 , ... Groove Ring is ... word about their high performance silicon wedding bands and all-purpose rings. Whether you’re an ... active, silicone rings designed just for you. , From the rock face to the ...
Breaking Medicine News(10 mins):