Allegedly Defective Balt USA Catheters Issued a Class I Recall Due to Serious Health and Death Risks

SANTA ANA, Calif. — The U.S. Food and Drug Administration has announced a recall of select Balt USA catheters after a manufacturing defect was discovered involving hydrophilic coating found inside the device’s inner tubing.

The recall is classified as a Class I event, the agency’s most serious designation, indicating that use of the device could lead to severe injury or death.

The affected product, the Mega Ballast Distal Access Platform, is a single-use catheter intended to assist clinicians in navigating blood vessels during cardiovascular and neurovascular procedures. The system includes a dilator coated with a lubricious material meant to reduce friction during use. The coating was unintentionally deposited inside the catheter’s inner tube, creating a potentially dangerous defect.

Officials warn that using an impacted device may result in blood clots, vessel damage, blocked arteries, stroke, impaired blood flow, nerve injury, infection, harmful immune responses, loss of brain function, or death. Hospitals are instructed to stop using the product immediately and ensure staff are notified. Distributors have been directed to halt sales, return existing inventory, and inform customers.

The recall applies to the following models and unique device identifiers:

• Model MEGABT09180 — UDI 00840303711780
  • Model MEGABT09190 — UDI 00840303711797
  • Model MEGABT091100 — UDI 00840303711803
  • Model MEGABT091110 — UDI 00840303711810

Contact The Ammons Law Firm if You or a Loved One Were Injured by a Recalled Medical Device

Medical devices are used in some of the most critical moments of care. Patients trust that the device intended to help them is doing just that and not causing harm.

Defective or recalled medical devices can cause serious injuries, and in some cases even death. If you or your loved one suffered because of a defective medical device, you may be entitled to compensation for medical expenses, lost income, pain and suffering, wrongful death damages, and other related losses.

Our recalled medical device attorneys are here to guide you and help you pursue the accountability and recovery you deserve.