MicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination
MicroVention is recalling 34 units of Traxcess 7 Mini Guidewires because the hydrophilic coating may delaminate from 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: The recall is classified as FDA Class II, and the hazard involves a structural defect (coating delamination) in a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
MicroVention, Inc. is recalling 34 units of the MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating (Ref GW0721006M). The recall involves lot numbers 17030521, 17032821, and 17041831. The product is a sterile, prescription-only medical device distributed to medical facilities in Arizona, California, Colorado, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Utah, Virginia, and Wisconsin.
The recall was initiated because there is a potential for the hydrophilic coating on the guidewire to delaminate from the device. No foreign, military, or government distribution occurred. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities that received these guidewires should stop using the affected units and contact MicroVention, Inc. for further instructions on the recall process.
The recalled product
- Product
- MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
- Manufacturer
- Microvention, Inc.
- Hazard
- Affected units
- 34
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 (3)
- Lot numbers 17030521
- 17032821
- and 17041831
Distribution
Related recalls
Same manufacturer · Microvention, Inc.
See all →- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereLVIS Intraluminal Support Device Stent Recalled Dimensional Nonconformance
FDA (Devices) · 2026-05-20
- HighFlow diverter devices recalled over tantalum defect affecting vessel wall apposition
FDA (Devices) · 2025-10-22
- HighLIFEPEARL microspheres are smaller than specification, risking non-targeted embolization
FDA (Devices) · 2025-08-06
- HighLVIS Intraluminal Support Device May Fail to Deploy Properly
FDA (Devices) · 2025-02-19
Same hazard · coating delamination
See all →- CriticalDistal access catheters recalled after coating material lifting inside the lumen
FDA (Devices) · 2025-11-05
- SevereCenterline Biomedical IOPS Guidewire 2 Coating Delamination Risk
FDA (Devices) · 2025-05-28
- CriticalFDA Recalls Pipeline Embolization Devices Due to Coating Delamination
FDA (Devices) · 2016-11-16
- SevereEv3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
FDA (Devices) · 2016-11-16
- CriticalFDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk
FDA (Devices) · 2014-04-23
Similar recalls
- SevereEv3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
FDA (Devices) · 2016-11-16
- SevereMedtronic Zinger Guidewires Recalled for Coating Delamination Risk
FDA (Devices) · 2013-11-27
- ModerateTERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation
FDA (Devices) · 2024-02-07
- SevereMedtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk
FDA (Devices) · 2013-11-27
- SevereMedtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk
FDA (Devices) · 2013-11-27
- ModerateAbbott Recalls HT Connect Peripheral Guide Wires Due to Coating Delamination
FDA (Devices) · 2014-01-01