ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CAL...

FDA Device Recall #Z-3022-2018 — Class II — August 10, 2018

Recall Summary

Recall Number Z-3022-2018
Classification Class II — Moderate risk
Date Initiated August 10, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Micro Therapeutics Inc, Dba Ev3 Neurovascular
Location Irvine, CA
Product Type Devices
Quantity 67 units

Product Description

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 Pattern

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

Lot / Code Information

Lot Number A495368

Other Recalls from Micro Therapeutics Inc, Dba Ev3 Neuro...

Recall # Classification Product Date
Z-1527-2020 Class I ev3 Pipeline Flex Embolization Device. For neu... Feb 14, 2020
Z-1528-2020 Class I ev3 Pipeline Flex Embolization Device with Shie... Feb 14, 2020
Z-1701-2018 Class I MindFrame Capture LP Revascularization Devices:... Feb 26, 2018
Z-0309-2017 Class I Marathon Flow Directed Micro Catheter, UltraFlo... Oct 5, 2016
Z-0310-2017 Class I X-Celerator Hydrophilic Exchange Guidewire C... Oct 5, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.