Recall Z-0188-2026 ยท DQY Catheter, Percutaneous
BALT USA, LLC
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 guid
| Date | Oct 24, 2025 (initiated Sep 25, 2025) |
| Status | Open, Classified |
| Reason | Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. |
| Root cause | Process control |
| Action | 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, purchas |
| Quantity | 207 catheters |
| Distribution | US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242376 | Next Generation Access Platform Balt USA, LLC, Dec 30, 2024 |