FDA Recalls Echelon-14 Microcatheters Due to Moisture-Exposed Packaging
Micro Therapeutics is recalling Echelon-14 microcatheters whose outer carton packaging was exposed to a wet substance during transport, posing a risk to device sterility.
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 3/5 (High).
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: FDA Class II medical device recall for actual packaging damage with potential sterility compromise. No illnesses or injuries reported, making this a preventive recall for a high-risk product category before clinical impact occurs.
Plain-English summary
Micro Therapeutics, Inc. is recalling Echelon-14, 45 Tip Shape microcatheters (lot B177543). These sterile, prescription-only medical devices are used in intravascular procedures.
During transport, the outer carton packaging of these microcatheters was exposed to a wet substance. Moisture exposure to the packaging poses a risk to the sterility of these devices.
The recalled product
- Product
- Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
- Manufacturer
- Micro Therapeutics, Inc.
- Affected units
- 8
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 (1)
- Lot # B177543 UDI: (00) 847536006270
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Micro Therapeutics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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