Balt USA, LLC medical device recall: Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97661
- Recall initiated
- Sep 25, 2025
- Classified by FDA
- Oct 24, 2025
- Posted in Enforcement Report
- Nov 5, 2025
- Recalling firm
- BALT USA, LLC
- Firm location
- Irvine, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 25, 2025. FDA classified it 29 days later, on Oct 24, 2025. Distribution reported by FDA: US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT. BALT USA, LLC has 6 recalls in our records.
Recalled products (1)
Z-0188-2026 Class I Ongoing
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 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
Codes / lots: 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
Quantity: 207 catheters
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97661
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.