Distal access catheters recalled after coating material lifting inside the lumen
Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The MEGA Ballast Distal Access Platform, model numbers MEGABT09180, MEGABT09190, MEGABT091100 and MEGABT091110, from Balt USA, is being recalled. The Mega Ballast 091 is a catheter with a semi-rigid proximal shaft and a highly flexible distal shaft, designed to be advanced through tortuous vasculature over a guidewire and dilator, with a hydrophilic coating from the tip to 40 cm proximal.
The recall follows an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter and lumen.
The recall covers 207 catheters distributed in Alabama, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Massachusetts, New York, Tennessee, Texas and Utah. The FDA has classified the recall as Class I, its most serious category, which the agency uses where there is a reasonable probability of serious injury or death.
Facilities should quarantine affected stock immediately and follow Balt USA's instructions.
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…
- Manufacturer
- BALT USA, LLC
- Category
- Medical Device — Catheter
- Affected units
- 207
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
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