Ev3 Neurovascular Recalls Marathon and UltraFlow Micro Catheters
Micro Therapeutics Inc. is recalling Marathon and UltraFlow HPC Flow Directed Micro Catheters because PTFE coating may delaminate and enter the bloodstream.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream."
Plain-English summary
Micro Therapeutics Inc., doing business as Ev3 Neurovascular, is recalling Marathon Flow Directed Micro Catheters and UltraFlow HPC Flow Directed Micro Catheters. The recall involves 66,429 units distributed worldwide, including the United States and numerous international markets.
The recall is due to a potential defect where the PTFE (polytetrafluoroethylene) coating material may delaminate and detach. This could lead to PTFE coating material entering the patient's bloodstream. The devices are intended for accessing peripheral and neurovasculature for the controlled selective infusion of therapeutic agents, such as embolization materials, and diagnostic materials, such as contrast media.
Healthcare providers and patients should check their inventory and patient records for the affected catalog numbers and lot codes listed in the official recall notice. If you have used these devices, contact your healthcare provider for guidance.
The recalled product
- Product
- Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and…
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Catheter
- Affected units
- 66,429
Distribution
Part of a larger recall action
This product is one of 4 recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular 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 4 products in this recall →Related recalls
Same manufacturer · Micro Therapeutics Inc, Dba Ev3 Neurovascular
See all →- SevereEv3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
FDA (Devices) · 2020-04-01
- Severeev3 Pipeline Flex Embolization Device Recalled for Potential Fracture
FDA (Devices) · 2020-04-01
- Moderateev3 TurboHawk Peripheral Plaque Excision System Recall for Incompatible Accessories
FDA (Devices) · 2018-09-19
- SevereEv3 MindFrame Capture Devices Recalled for Potential Wire Separation
FDA (Devices) · 2018-05-23
- CriticalFDA Recalls Pipeline Embolization Devices Due to Coating Delamination
FDA (Devices) · 2016-11-16
Same hazard · foreign body
See all →- HighHortex Mieszanka 9 Spring Vegetable Mix Recalled for Potential Glass Contamination
FDA (Food) · 2026-03-18
- HighBlunt tip sealers 44 cm recalled over trapped residual material
FDA (Devices) · 2025-11-19
- HighSmall jaw sealers recalled over residual material that may dislodge
FDA (Devices) · 2025-11-19
- HighShort blunt tip sealers recalled over residual material that may dislodge
FDA (Devices) · 2025-11-19
- HighBlunt tip sealers recalled over residual material trapped inside the device
FDA (Devices) · 2025-11-19
Similar recalls
- ModerateEv3 Neurovascular Recalls Mislabeled Marathon Flow Directed Micro Catheters
FDA (Devices) · 2012-10-03
- ModerateEv3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters
FDA (Devices) · 2012-10-03
- SevereEv3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
FDA (Devices) · 2014-04-23
- Severeev3 Pipeline Flex Embolization Device Recalled for Potential Fracture
FDA (Devices) · 2020-04-01
- SevereEv3 MindFrame Capture Devices Recalled for Potential Wire Separation
FDA (Devices) · 2018-05-23
- ModerateEv3 Neurovascular Recalls Pipeline Embolization Devices Due to Incorrect Instructions
FDA (Devices) · 2015-10-21