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:6/26/2016)... June 27, 2016  VMS Rehab Systems, Inc. ( ... take whatever measures required to build a strong and ... is currently listed on the OTC Markets-pink current trading ... and CEO, "We are seeing an anomaly in market ... not only by the Company, but shareholders and market ...
(Date:6/24/2016)... , June 24, 2016  Global Blood Therapeutics, ... company developing novel therapeutics for the treatment of ... announced the closing of its previously announced underwritten ... at the public offering price of $18.75 per ... were offered by GBT. GBT estimates net proceeds ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... Canada (PRWEB) , ... June 25, 2016 , ... Conventional ... pursuit of success. In terms of the latter, setting the bar too high can ... risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
Breaking Medicine News(10 mins):