Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0
Summary
The FDA issued a Class I for Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800 by Datascope Corp.. Reason: IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is di.
Details
Source
Device Recall
External ID
Z-2149-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
Lot/Code Info: All Unit Serial Numbers Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432
Quantity Affected: 9174 (4586 US; 4588 OUS)
Reason for Recall
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: ALBANIA ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GHANA, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM, YEMEN, ZAMBIA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-05
Company
Mahwah, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Datascope Corp. has 58 FDA actions in our database, including 58 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Datascope Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Datascope Corp. have FDA actions?
Datascope Corp. has 58 FDA actions in our database, including 58 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2149-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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