Quick Facts at a Glance
- Recall Date
- January 23, 2026
- 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 (IABP)
- Model numbers
- CS300 IABP CS300 IABP C.01
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 23, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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
CS300 IABP is a specialized cardiac support device used in clinical settings to assist heart function. It is typically managed by healthcare facilities and clinicians.
Why This Is Dangerous
The recall addresses updates needed to battery runtime and cycle specifications in the IFU, which could impact device operation guidance.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The immediate action required is to halt use of affected devices and await manufacturer guidance, which may affect procurement and clinical workflows.
Practical Guidance
How to identify if yours is affected
- Verify model and software version CS300 IABP C.01 on the device label or IFU.
- Check if the device in use matches CS300 IABP CS300 IABP C.01 version.
- Consult the facility’s biomedical engineering team for inventory checks.
Where to find product info
Recall number Z-1487-2026 on the FDA enforcement page and manufacturer communications.
What timeline to expect
Refunds or replacements are typically processed after manufacturer remediation steps, but no firm timeline is provided in the recall notice (investor/
If the manufacturer is unresponsive
- Escalate to hospital compliance or legal teams.
- Document all communications with the manufacturer and regulators.
How to prevent similar issues
- Maintain updated contact lists for manufacturers and regulatory notices.
Documentation advice
Keep recall notices, correspondence, inventory lists of affected devices, and any disposal or quarantine actions.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: CS300 IABP CS300 IABP C.01. Sold worldwide through healthcare providers. Sold date and price not specified.
Key Facts
- Recall involves 10,897 units
- Worldwide distribution including the US
- Hazard level HIGH
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.