The FDA has flagged a critical recall concerning Balt USA’s Mega Ballast Distal Access Platform devices, identified as carrying a significant risk of adverse health outcomes. Health care professionals, distributors, and clinical teams should cease use and follow recall procedures immediately to safeguard patient health.
Why was the recall initiated?
Balt USA initiated the recall after discovering a manufacturing defect wherein hydrophilic coating material had been mistakenly applied inside the inner lumen at the distal end of the catheter. Hydrophilic coating is intended for the outer surface of the catheter’s tip to aid navigation but should not exist inside the device’s tubing. The presence of this material within the inner lumen poses potential health risks such as:
- Blood clots that may travel to critical organs
- Direct damage to blood vessels
- Blocked blood flow and stroke
- Immune system reactions
- Infections
- Nerve damage
- Loss of brain function, and potentially death
As of September 19, 2025, Balt USA has confirmed that no injuries or fatalities linked to this issue have been reported.
Who is affected by this recall?
The recall affects both hospital staff using these devices and distributors handling the products. Specific model numbers and lot/serial numbers of the Mega Ballast Distal Access Platform have been identified, including:
- Model Nos: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110
- Serial Numbers: F250600687, F250600686, F250600685, and others listed in the recall notification
All personnel handling these devices should locate affected products, cease their use, and follow the outlined return procedures immediately.
Steps to take
For hospital staff
Hospital personnel should take the following actions:
- Immediately discontinue use of affected Mega Ballast devices.
- Inform all staff members about the recall.
- Quarantine the affected devices and arrange their return to Balt USA.
Hospitals should contact the Balt USA Quality Department directly at 1-949-788-1443 or QA@baltgroup.com for assistance.
For distributors
Distributors should:
- Cease processing the recalled devices.
- Notify their customers about the recall.
- Ensure that all affected products are identified, quarantined, and returned following the prescribed protocol.
Distributors are advised to coordinate returns through their local distributor or Balt USA customer service.
About the Mega Ballast Distal Access Platform
The Mega Ballast Distal Access Platform is a single-use medical device designed to navigate curved and winding blood vessels. The device features:
- A semi-rigid back section for stability
- A flexible front section capable of maneuvering tight spaces
- Special hydrophilic coating on the outer surface of the front section for smooth navigation
Its intended purpose is aiding physicians during procedures requiring catheterization of complex vascular structures using a guidewire and dilator. This recall arises specifically due to unintended coating material inside the catheter that undermines device safety.
What does this mean moving forward?
This recall highlights the importance of ensuring manufacturing precision in medical devices and the rapid identification of defects via FDA monitoring systems. Health care facilities and distributors are advised to act decisively. Balt USA has provided avenues for communication and product returns, minimizing risk to patient safety.
Disclaimer
This article is for informational purposes only and is not legal or medical advice. Clinical professionals should refer directly to FDA communications and consult regulatory compliance teams as needed.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-balt-usa-removes-mega-ballast-distal-access-platform