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
Recall
- Recall Number
- Z-0188-2026
- Event Number
- 97661
- Firm
- BALT USA, LLC
- FEI Number
- 3014162263
- Product Code
- DQY
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 25, 2025
- Posted
- October 24, 2025
- Address
- 29 Parker, Ste 100, Irvine, CA, 92618-1667
Description
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
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
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: [email protected] Balt USA, LLC 29 Parker Suite 100 | Irvine CA, 92618 | USA Telephone: +949.788.1443 | Fax: +949.788.1444
US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.
207 catheters