Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099
Summary
The FDA issued a Class I for Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-3 by Datascope Corp.. Reason: The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic b.
Details
Source
Device Recall
External ID
Z-0885-2023
Action Date
2023-01-25
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, 0998-00-0800-36, 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-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65.
Lot/Code Info: All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-00-0800-33, 10607567109053; 0998-00-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 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; 0998-UC-0800-31, 10607567109053; 0998-UC-0800-32, 10607567111117; 0998-UC-0800-33, 10607567109008; 0998-UC-0800-34, 10607567111940; 0998-UC-0800-35, 10607567109107; 0998-UC-0800-36, 10607567114187; 0998-UC-0800-45, 10607567108421; 0998-UC-0800-52, 10607567108438; 0998-UC-0800-53, 10607567108391; 0998-UC-0800-55, 10607567108414; 0998-UC-0800-65, 10607567113432.
Quantity Affected: 11,906 Total
Reason for Recall
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Distribution
Worldwide Distribution - US Nationwide and the countries of Albania, 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, Reunion, 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, Vietnam, Yemen, and Zambia.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-19
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 149 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-0885-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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