Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT0919
FDA device recall Z-0188-2026 · posted 2025-10-24 · Open, Classified
Recall details
- Recalling firm
- BALT USA, LLC
- Reason for recall
- Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DQY
- Quantity affected
- 207 catheters
- Distribution
- US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.
- Date initiated
- 2025-09-25
- Date posted
- 2025-10-24
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Next Generation Access Platform (K242376) | Balt USA, LLC | 2024-12-30 |