Echelon-14 Micro Catheter Recall Due to Moisture Exposure During Transport
Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.
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: This is a sterile medical device recall where moisture exposure to packaging presents a risk of harm through potential loss of sterility or device function. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Micro Therapeutics, Inc. is recalling the Echelon-14 Micro Catheter (Reference 105-5092-150) due to moisture exposure of the outer carton packaging during transport. The recalled lot is B262322, affecting two units.
The Echelon-14 Micro Catheter is a sterile medical device used in interventional procedures. Moisture exposure to the outer carton packaging can compromise the sterility and integrity of the device.
If you have received one of these devices, contact your healthcare provider or Micro Therapeutics, Inc. for instructions on what to do next. Do not use the device if it remains unopened or in inventory.
The recalled product
- Product
- Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
- Manufacturer
- Micro Therapeutics, Inc.
- Category
- Medical Device
- Affected units
- 2
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 # B262322 UDI: (00) 847536005983
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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