MEGA Ballast Catheter Recall: Coating Lifting Risk
U.S. recall of Mega Ballast catheters (models MEGABT09180-091110) due to coating lifting in distal lumen. Stop using if you own these models.
Use caution until it’s fixed
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Contact the company
What happened, in plain English
The U.S. government recalls Mega Ballast catheters with model numbers MEGABT09180 through MEGABT091110 because coating material can lift inside the catheter's tip. This defect may cause blockages or complications during medical procedures. Read more at govinfonow.com/recall/51225-mega-ballast-catheter-recall-coating-lifting-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51225-mega-ballast-catheter-recall-coating-lifting-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0188-2026
Cite this page
“MEGA Ballast Catheter Recall: Coating Lifting Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51225-mega-ballast-catheter-recall-coating-lifting-risk. Based on FDA recall #Z-0188-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0188-2026%22&limit=1).
Why it’s dangerous
The coating on the catheter's tip can lift due to a manufacturing defect, potentially causing blockages or complications during medical procedures. This may lead to treatment delays or additional medical interventions.
Who’s affected
Patients using these catheters for medical procedures are affected. Healthcare providers who use the device for vascular access are most at risk.
How to tell if you have this one
Check for model numbers MEGABT09180, MEGABT09190, MEGABT091100, or MEGABT091110 on the device. The product was sold with lot numbers starting with F250.
- Brand
MEGA Ballast- Category
Medical device
What to do — step by step
Check Model Number
Look for model numbers MEGABT09180, MEGABT09190, MEGABT091100, or MEGABT091110 on the device.
Stop Using Immediately
If you have the recalled model, stop using the catheter immediately to prevent potential blockages or complications.
Where it went and when
Where it was distributed
Distributed in 12 states.
FDA distribution: “US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Massachusetts, New York, Tennessee, Texas, Utah.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0188-2026 (September 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0188-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.