Datascope MEGA 7.1 Fr. 40cc Intra-Aortic Balloon Recall: Labeling Discrepancy
Datascope recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories (Model 0684-00-0295-01) due to discrepant labeling on inner and outer packaging. Affected units may have safety risks.
Lower-risk recall
There is discrepant labeling on the inner and outer packaging of the device.
Contact the company
What happened, in plain English
Datascope is recalling a specific model of intra-aortic balloon catheter because the inner and outer packaging have different labels. This labeling issue could lead to confusion about the product's specifications, potentially affecting safe medical use. Read more at govinfonow.com/recall/54015-datascope-mega-7-1-fr-40cc-intra-aortic-balloon-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/54015-datascope-mega-7-1-fr-40cc-intra-aortic-balloon-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0311-2025
Cite this page
“Datascope MEGA 7.1 Fr. 40cc Intra-Aortic Balloon Recall: Labeling Discrepancy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54015-datascope-mega-7-1-fr-40cc-intra-aortic-balloon-recall. Based on FDA recall #Z-0311-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0311-2025%22&limit=1).
Why it’s dangerous
The inner and outer packaging have different labels, which could lead to confusion about the product's specifications. This might result in incorrect use during medical procedures, potentially affecting patient safety.
Who’s affected
Healthcare professionals who use this specific model of intra-aortic balloon catheter are likely affected. Patients receiving this device during procedures may be at risk if the labeling discrepancy causes incorrect usage.
How to tell if you have this one
Check for the model number 0684-00-0295-01 on the packaging. The device also has a unique identifier (UDI-DI: 10607567107974) and lot number 3000344298.
- Brand
Datascope- Category
Medical device
What to do — step by step
Check Packaging Labels
Verify that the inner and outer packaging match the model number 0684-00-0295-01 and lot number 3000344298.
How this recall unfolded
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
The recall does not require immediate action. Check the packaging labels to confirm if the product matches the recalled model.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0311-2025 (September 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0311-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.