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) Controller Software
- Model numbers
- All Model No, All UDI, All Serial No.
- 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
CS100 IABP is a hospital-use cardiology device used to support the heart by inflating a sleeve in the aorta during cardiac procedures.
Why This Is Dangerous
The hazard stems from outdated battery runtime and cycle specifications in the Instructions for Use, which could affect device performance.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and patients must stop using the device until updated IFU guidance is applied. No injuries are reported, but the risk is potential misoperation if specifications are not updated.
Practical Guidance
How to identify if yours is affected
- Confirm device model is CS100 IABP with software CS100 IABP Q.01.
- Check device documentation for the model/UDI/serials: All Model No, All UDI, All Serial No.
- Review recall notice for instructions.
Where to find product info
Recall details are posted on the FDA enforcement page and should be in manufacturer communications. The URL provided in the notice is the primary reference.
What timeline to expect
The recall process timeline for updates and guidance is not specified.
If the manufacturer is unresponsive
- Escalate through hospital risk management and supply chain.
- Contact FDA or local health authority if the manufacturer is unresponsive.
How to prevent similar issues
- Ensure IFU materials in use match the recall version.
- Maintain a list of affected devices in hospital inventory.
- Coordinate firmware/software updates with the manufacturer.
Documentation advice
Keep a copy of the recall notice, track device identifiers, document communications with the manufacturer, and preserve any failure reports.
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Product Details
Model numbers: All Model No. All UDI. All Serial No. Where sold: Worldwide distribution, including US nationwide and the listed countries. When sold: Unknown Price: Unknown
Key Facts
- Quantity recalled: 10,897 units
- Product: CS100 IABP, software CS100 IABP Q.01
- Hazard: Battery runtime and cycle specifications require updating in IFU
- Distribution: Worldwide including US and numerous countries
- Model numbers: All Model No, All UDI, All Serial No
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Safety Guide
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