[pending] Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: M
Pending LLM rewrite. Source: FDA_DEVICE Z-0188-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
The recalled product
- Product
- 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 flex
- Manufacturer
- BALT USA, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- F250600686
- F250600685
- F250600455
- F250600346
- F250600345
- F250600010
- F250501434
- F250501346
- F250501091
- F250500824
- F250400219
- F250400024
- F250301020
- F250300297
- F250100956
Distribution
Distributed in 12 states:
- AL
- CA
- CO
- CT
- FL
- IL
- KY
- MA
- NY
- TN
- TX
- UT
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