Merit Medical Systems Recalls Maestro Microcatheters Due to Label Graphic Discrepancy
Merit Medical Systems is recalling 59 Maestro Microcatheters because the graphic on the carton's end panel does not match the front panel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a cosmetic labeling discrepancy (mismatched graphics) with no reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Merit Medical Systems, Inc. is conducting a recall for 59 units of Maestro Microcatheters. The recall involves three specific lots: Catalog Number 28MC24110ST with Lot Number H548211, and Catalog Number 28MC24130SN with Lot Numbers H549598 or H553237.
The reason for the recall is a graphic discrepancy on the carton and box labels. Specifically, the catheter graphic displayed on the front of the carton box is correct, but the graphic on the end panel is incorrect and does not match the front. This is a labeling error rather than a defect in the catheter itself.
The affected products were distributed nationwide in the United States and internationally to Canada. The source text does not specify any reported illnesses, injuries, or adverse health consequences associated with this labeling discrepancy. Users should verify the catalog and lot numbers of their devices against the list provided in this notice.
The recalled product
- Product
- Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 59
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 (3)
- Catalog Numbers: 28MC24110ST with Lot Number: H548211
- and Catalog Number: 28MC24130SN with Lot Numbers: H549598
- or H553237
Distribution
Distributed nationwide across the United States.
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