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.
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: 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Micro Therapeutics, Inc.
See all →- ModerateEmbolization devices recalled due to incorrect labeling of implant dimensions
FDA (Devices) · 2026-07-29
- ModeratePipeline Flex Embolization Devices Recalled Due to Incorrect Labeling of Implant Length
FDA (Devices) · 2026-07-29
- SevereMedtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk
FDA (Devices) · 2025-03-12
- SevereMedtronic Pipeline Vantage device recall: deformation may cause blood clots
FDA (Devices) · 2025-03-12
- HighFDA Recalls Apollo Onyx Delivery Microcatheter Due to Labeling Mismatch
FDA (Devices) · 2024-03-13
Same hazard · moisture exposure
See all →- ModerateTeleflex Recalls RUSCH LASERTUBE Devices Due to Laser Guard Foil Separation
FDA (Devices) · 2020-07-15
- ModeratebioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals
FDA (Devices) · 2020-04-01
- ModerateAmerican Health Packaging Recalls Desmopressin Acetate Tablets Due to Missing Desiccant
FDA (Drugs) · 2020-02-26
- ModeratePfizer Recalls Caduet Tablets Due to Defective Bottle Seals
FDA (Drugs) · 2020-02-19
- ModeratePfizer Recalls Caduet Tablets Due to Defective Bottle Seals
FDA (Drugs) · 2020-02-19