-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Fl...

FDA Device Recall #Z-0120-2016 — Class II — September 4, 2015

Recall Summary

Recall Number Z-0120-2016
Classification Class II — Moderate risk
Date Initiated September 4, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Micro Therapeutics Inc, Dba Ev3 Neurovascular
Location Irvine, CA
Product Type Devices
Quantity 23 devices

Product Description

-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.

Reason for Recall

The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.

Distribution Pattern

US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees.

Lot / Code Information

Pipeline Model Number Lot Number FA-77250-16V06 9724629 FA-77350-16V10 A024276 FA-77350-16V12 A012865 FA-77350-18Vl0 A013596 FA-77350-20V12 A012039 FA-77375-14V12 A013029 FA-77375-16Vl2 A011629 FA-77375-16Vl2 A029223 FA-77375-16Vl2 A031361 FA-77375-18V10 A024213 FA-77375-20Vl2 A029315 FA-77400-14V12 A012885 FA-77425-18V12 A026942 FA-77450-14V12 A013028 FA-77475-20Vl2 A012383 FA-77500-16Vl2 A029316 Pipeline Flex Model Number Lot Number PED-400-20VO1 9977371 PED-475-20V01 A047151 PED-375-18V01 9971250

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

Recall # Classification Product Date
Z-1528-2020 Class I ev3 Pipeline Flex Embolization Device with Shie... Feb 14, 2020
Z-1527-2020 Class I ev3 Pipeline Flex Embolization Device. For neu... Feb 14, 2020
Z-3022-2018 Class II ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM ... Aug 10, 2018
Z-1701-2018 Class I MindFrame Capture LP Revascularization Devices:... Feb 26, 2018
Z-0307-2017 Class I Pipeline Embolization Device (Pipeline Classic)... 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.