Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall MEGA Ballast Distal Access Platform (originally cleared as Next Generation Access Platform)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall MEGA Ballast Distal Access Platform (originally cleared as Next Generation Access Platform)see related information
Date Initiated by FirmSeptember 25, 2025
Date PostedOctober 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0188-2026
Recall Event ID 97661
510(K)NumberK242376 
Product Classification Catheter, percutaneous - Product Code DQY
ProductBrand 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 coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component
Code Information 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
Recalling Firm/
Manufacturer		 BALT USA, LLC
29 Parker Ste 100
Irvine CA 92618-1667
For Additional Information ContactMr. David Vu
+1-949-7881443
Manufacturer Reason
for Recall		Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce207 catheters
DistributionUS distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQY
-
-