Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-08
Summary
The FDA issued a Class I for Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998 by Datascope Corp.. Reason: Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leadin.
Details
Source
Device Recall
External ID
Z-0337-2022
Action Date
2021-12-22
Status
Ongoing
Category
device
Product Description
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Lot/Code Info: All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-UC-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-UC-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-85, 10607567113449.
Quantity Affected: 44 (US); 5 (OUS)
Reason for Recall
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Distribution
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-15
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 193 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-0337-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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