Cardiosave Hybrid Intra-Aortic Balloon Pump recall
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…
Why was Cardiosave Hybrid Intra-Aortic Balloon Pump recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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…
- Recalling firm
- Datascope Corp.
- Quantity
- 11,906 Total
- 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.
- Recall date
- January 25, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)