- Maquet Datascope Corp
- Datascope Iabp
- Datascope Communications Phils Inc
- Datascope Corporation
- Serial Data Scope Maquette
- Maquet Iabp
All Serial Numbers distributed from to: Recalling Firm/. Affected customers will be contacted by a Maquet/Getinge representative to schedule on-site service of your Cardiosave IABP by a Maquet/ Getinge Sales or Service Re. S with Product Code = DSP and Original Applicant = DATASCOPE CORP. - - Links on this page: Page. Serial numbers: All Serial Numbers manufactured from December 12, 2011 and ongoing are affected. Maquet Datascope Corp. Is recalling the Cardiosave Hybrid and Cardiosave Rescue IABPs due to the.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Name: Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs)
- Serial numbers: All Serial Numbers manufactured from December 12, 2011 and ongoing are affected
- Model/Product UPN Codes:
- Cardiosave Hybrid: 0998-00-0800-XX
- Cardiosave Rescue: 0998-UC-0800-XX
- Manufacturing Dates: All units manufactured since December 12, 2011 and ongoing
- Distribution Dates: March 6, 2012 to August 31, 2018
- Devices recalled in the U.S: 2876 units
Device Use
The Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
Reason for Recall
Maquet Datascope Corp. is recalling the Cardiosave Hybrid and Cardiosave Rescue IABPs due to the potential of the autofill process to malfunction or fail during use at altitudes above 3200 feet. This failure may result in either interruption or cessation of therapy upon the first maintenance autofill or the inability to start therapy.
Who May be Affected
- Health care providers who use the Cardiosave Hybrid and Cardiosave Rescue IABPs.
- Patients receiving circulatory support with a Maquet Datascope Corp.'s Cardiosave Hybrid and Cardiosave Rescue IABPs.
What to Do
On September 24, 2018, Maquet Datascope Corp. issued an Urgent Device Correction letter to all device consignees along with an Instructions for Use Addendum. The letter instructed users to follow the operating altitudes permissible for certain intra-aortic balloons, as specified below for the Cardiosave Hybrid and Cardiosave Rescue IABPs:
| Balloon Name and Size | Operating Altitude |
|---|---|
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|
|
|
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Alternatively, use a Cardiosave CS100 or CS300 IABP, since they are not affected by this issue.
Maquet/Getinge is also currently developing a software correction to address this issue. Maquet/Getinge anticipates installing the updated software beginning in February 2019. A Maquet/Getinge Service representative will contact customers to schedule software installation at no cost.
Maquet Datascope Corp
Contact Information
Customers with questions may contact Maquet Datascope Corp's Technical Support Department at 1-888-627-8383 (press option 3), Monday through Friday, between 8:00 am and 6:00 pm Eastern Standard Time.
Date Recall Initiated
September 20, 2018
How Do I Report a Problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
WAYNE, N.J., May 9, 2014 /PRNewswire/ -- In March 2014, 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 for a potential mechanical failure of the fan assembly associated with the power supply. All customers that may have an intra-aortic balloon pump affected by this field correction have been notified. There are approximately 12,360 affected units sold globally.
The intra-aortic balloon pump is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle via the principle of counterpulsation.
As a result of customer complaints related to a malfunction of the System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps (IABP), Datascope Corp/MAQUET conducted an investigation and identified a 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. An IABP shutdown could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.
Datascope Iabp
Between January 1, 2003 and June 30, 2011, specific System 98/98XT, CS100/CS100i and CS300 IABPs were manufactured with an affected fan assembly, or may have received an affected fan assembly during an upgrade/service of the IABP in the field. The affected IABP units were distributed in the US and worldwide (in over 100 countries). The affected IABP's can be identified by part and serial number. Each MAQUET Service Representative has a list of the affected serial numbers and will check each affected part during the corrective action.
Datascope Communications Phils Inc
The affected System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps involved in the field correction can be used while waiting for parts and service. Customers should adhere to the instructions for use when using an affected intra-aortic balloon pump.
The U.S. Food and Drug Administration ('FDA') has classified this action as a Class 1 recall. FDA defines Class 1 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.' To date, there have been no reported patient injuries or deaths related to the power supply malfunction.
The corrective action associated with this recall is to provide a replacement fan assembly to all IABPs containing an affected fan assembly. A MAQUET Service Representative will contact those facilities with affected IABP's to schedule corrective action and document this corrective action during a visit to the customer.
Datascope Corporation
For additional information regarding this field correction, please contact the Technical Support Department at 1-800-777-4222 and Press 3 (Monday through Friday from 8:00 am – 6:00 pm EST).
Serial Data Scope Maquette
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Maquet Iabp
SOURCE MAQUET