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): D998-00-0800-31 (10607567109053), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391) +8 more
- 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 Intra-Aortic Balloon Pump is a medical device used to assist patients with severe cardiac conditions. It is employed during procedures to help improve blood flow and decrease the workload on the heart.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act immediately to avoid potential risks associated with using the affected devices. The recall may cause disruptions in patient care but is necessary for ensuring safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your Intra-Aortic Balloon Pump device.
- Compare the model number with those listed in the recall notice.
- If your model is listed, it is affected by the recall.
Where to find product info
Model numbers can typically be found on the device label or in the user manual.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks once initiated.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Contact your healthcare provider for additional support.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- Always check for the latest updates on medical devices from manufacturers.
- Look for safety certifications when purchasing medical equipment.
- Stay informed about any recalls affecting your devices.
Documentation advice
Keep copies of all correspondence, receipts, and documentation related to the recall for your records.
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Key Facts
- Recall Date: November 4, 2025
- Quantity Recalled: 11,470 units
- Device Classification: Class II
- Affected Models: Multiple including D998-00-0800-31
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Safety Guide
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