PlainRecalls
FDA Devices Moderate Class II Terminated

-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

Reported: October 21, 2015 Initiated: September 4, 2015 #Z-0120-2016

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.

Details

Units Affected
23 devices
Distribution
US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees.
Location
Irvine, CA

Frequently Asked Questions

What product was recalled? ▼
-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.. Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular. Units affected: 23 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 21, 2015. Severity: Moderate. Recall number: Z-0120-2016.

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