The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0162-2015·Announced 2014-11-12

Merit Maestro Microcatheter Recalled for Incorrect Distal Tip Size

Merit Medical Systems is recalling 56 Maestro Microcatheters because they were packaged with a 2.8 F distal tip instead of the labeled 2.4 F.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a labeling/packaging discrepancy (incorrect tip size) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor labeling or packaging errors.

Plain-English summary

Merit Medical Systems, Inc. is recalling 56 units of Merit Maestro Microcatheters, 2.4F 130cm Straight (REF28MC24130ST). The recall involves specific lots of Catalog No. 28MC24130ST and Catalog No. 28MC24150SN. The products were distributed nationwide and to India.

The recall was initiated because the microcatheters were packaged with a 2.8 F distal tip, rather than the 2.4 F size indicated on the label. This discrepancy between the physical product and the labeling is the reason for the recall.

Healthcare providers and facilities that have received these specific lots should stop using the affected microcatheters and contact Merit Medical Systems for instructions on how to return the products. The recall is classified as Class II by the FDA.

The recalled product

Product
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Catheters
Hazard
Affected units
56

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 (6)

  • Catalog No: 28MC24130ST
  • Lot H665694
  • H669824
  • Exp 2017 and Catalog No: 28MC24150SN
  • Lot H665696
  • Exp 7/31/2014

Distribution

Distributed nationwide across the United States.

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