Micro Therapeutics Inc, Dba Ev3 Neurovascular: -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.

Recall number

Z-0120-2016

Recalling firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Product

-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.

Status

Terminated

Initiated

2015-09-04

Posted

2015-10-14

Terminated

2017-05-18

Reason

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.

Root cause

Process control

Action

The firm, Medtronic, sent a "Notification of Recall" letter dated 09/04/15 to its customers. The letter described the product, problem and actions to be taken. The firm's letter instructed that customers return the Pipeline Embolization Devices to Medtronic for replacement with the US version of product. The firm asks customers to take the following steps: 1) Stop using this product immediately. 2) Segregate this product from other Inventory. 3) Fill out the reply form and fax to the completed form directly to Customer Service at (800) 716-6700 or email to: andrew.schramm@medtronic.com. Customer Service will issue an RGA number for the return of the affected product back to Medtronic Neurovascular. 4) Upon receipt of an RGA number, write the RGA number on the FEDEX slip and send the product back to: Medtronic Neurovascular, Attention: Product Recall, 9775 Toledo Way, Irvine, CA 92618. Prepaid and preaddressed FEDEX slips are enclosed for convenience. 5. Once they receive the returned units, product replacement units will be shipped directly to customers. The local Neurovascular representative can also be available to assist in expediting the exchange of product. For any questions contact directly at 949-680-1340.

Quantity

23 devices

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

["P100018"]

Product code

OUT

Firm FEI

3004904811

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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