# FDA recall Z-3103-2017

> **Microvention, Inc.** · Class II · device recall initiated 2017-08-07.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-3103-2017
- **Recalling firm:** Microvention, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-07
- **Report date:** 2017-09-13
- **Termination date:** 2018-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3103-2017

## Citation

> AI Analytics. FDA recall Z-3103-2017. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-3103-2017. Source: US FDA. Licensed CC0.

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