MEGA Ballast Catheter Recall: Coating Lifting Risk

Take action

Contact the company & request your remedy

Recalling firmBALT USA, LLC29 Parker Ste 100, N/A · Irvine, CA 92618-1667

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

What is the risk of using this catheter?

The coating material can lift inside the catheter's tip, potentially causing blockages or complications during medical procedures.

How can I tell if I have the recalled model?

Check for model numbers MEGABT09180, MEGABT09190, MEGABT091100, or MEGABT091110 on the device. The product was sold with lot numbers starting with F250.

Is there a fix for this defect?

The recall does not provide a fix; the remedy is not stated in the record.

Take action

Contact MEGA Ballast

We’ve drafted a message you can send MEGA Ballast to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0188-2026 — MEGA Ballast MEGA Ballast

Hello,

I own a MEGA Ballast that is covered by recall Z-0188-2026 from MEGA Ballast.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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.

BALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180,

Use caution until it’s fixed