# FDA recall Z-3022-2018

> **Micro Therapeutics Inc, Dba Ev3 Neurovascular** · Class II · device recall initiated 2018-08-10.

## Product

ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C  for peripheral vascular use.

## Reason for recall

The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.

## Distribution

Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China

## Key facts

- **Recall number:** Z-3022-2018
- **Recalling firm:** Micro Therapeutics Inc, Dba Ev3 Neurovascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-10
- **Report date:** 2018-09-19
- **Termination date:** 2020-08-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3022-2018

## Citation

> AI Analytics. FDA recall Z-3022-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3022-2018. Source: US FDA. Licensed CC0.

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