MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Reported: September 13, 2017 Initiated: August 7, 2017 #Z-3103-2017
Product Description
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Reason for Recall
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Details
- Recalling Firm
- Microvention, Inc.
- Units Affected
- 34 units
- Distribution
- Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.. Recalled by Microvention, Inc.. Units affected: 34 units.
Why was this product recalled? ▼
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 13, 2017. Severity: Moderate. Recall number: Z-3103-2017.
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