Reported Oct 21, 2015 · Terminated

-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices…

Micro Therapeutics Inc., dba Ev3 Neurovascular

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Micro Therapeutics Inc, Dba Ev3 Neurovascular · 9775 Toledo Way · Irvine, CA · 92618-1811

Is this the product you have?

-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.

Lot codes and dates: 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
Amount recalled: 23 devices

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Medical device recalls

Other recalls from Micro Therapeutics Inc., dba Ev3 Neurovascular

7 in total.

Where it was distributed

All recall categories · Browse the whole archive