Quick Facts at a Glance
- Recall Date
- November 4, 2025
- Hazard Level
- HIGH
- Brand
- Datascope
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Datascope
- Product type
- Intra-Aortic Balloon Pump
- Model numbers
- Model No. (UDI): 0998-00-0800-83 (10607567108407), ALL SERIAL NO.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 4, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Datascope Corp. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Cardiosave Rescue Intra-Aortic Balloon Pump is a medical device used to assist patients with cardiac issues during critical care. Hospitals typically purchase this device for use in emergency and surgical settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate action from healthcare providers to ensure patient safety, potentially leading to disruptions in medical procedures.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device, which is 0998-00-0800-83.
- Verify if your device serial number is listed as affected.
- Check any documentation received with the device for recall notices.
Where to find product info
The model number and serial number are typically found on the back or bottom of the device.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication attempts with Datascope Corp.
- Follow up with a formal complaint if no response is received.
- Consider reporting the issue to relevant health authorities if unresolved.
How to prevent similar issues
- Verify that the product has up-to-date safety certifications before use.
- Research any recalls or safety notices that may affect the device.
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Product Details
The Cardiosave Rescue Intra-Aortic Balloon Pump, model number 0998-00-0800-83, is designed for use in critical care settings. It was distributed across multiple countries, including the United States and many international regions. The recall affects 47 units.
Key Facts
- Class II recall
- High hazard level
- Immediate action required
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Safety Guide
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