The Recall Desk
HighFDA (Devices)·Z-1556-2022·Announced 2022-08-24

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.

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: 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.
Category
Medical Device — Intravascular Microcatheter
Hazard
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.

See all 2 products in this recall →

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