MEGA Ballast Access Platform (BALT) – coating defect (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic c
Brand
BALT USA, LLC
Lot Codes / Batch Numbers
F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956
Products Sold
Model Numbers and UDI-DI codes: Model No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No MEGABT091100 (00840303711803) Model No MEGABT091110 (00840303711810) Lot Numbers: F250600687, F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956
BALT USA, LLC is recalling Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEG due to Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Recommended Action
Per FDA guidance
On 09/18/2025, the firm sent via Priority Mail an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that, Balt USA has became aware of a situation where multiple Mega Ballast units failed the in-house QC final inspection due to the exterior coating material lifting. Further assessment found this coating also went inside of the ID and protruded from the inner surface of the catheter, which is not intended as part of the manufacturing process. Hospitals are instructed to: - Cease use of the affected product. - Inform hospital staff, such as safety officers, pharmacists, purchasing agent, head of neuroradiology and the neuroradiology staff, physicians including but not limited to endovascular neurosurgeons and interventional neurologists, as well as any other person if deemed necessary. - Identify and locate the Mega Ballast products concerned by this recall procedure. - Collect and put in quarantine the Mega Ballast products concerned by this recall, then return them to Balt USA through the usual administrative returns procedure by contacting Balt USA s Customer Service department. Distributors are instructed to: - Cease processing of the affected recall product. - Inform customers about this notice. - Identify and locate the Mega Ballast products concerned by this recall procedure. - Collect and put in quarantine the Mega Ballast products concerned by this recall procedure and then return them to your local distributor as per their return procedure. For questions or further assistance: Contact: Quality Department Email: QA@baltgroup.com Balt USA, LLC 29 Parker Suite 100 | Irvine CA, 92618 | USA Telephone: +949.788.1443 | Fax: +949.788.1444
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, UT
Page updated: Jan 10, 2026