Z-0120-2016Class II

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

Name: Z-0120-2016 -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization...
Creator: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Published: 2015-09-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-09-04 / Terminated / root cause: manufacturing process

FDA source

Micro Therapeutics Inc, Dba Ev3 Neurovascular began a recall of -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined... on 2015-09-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0120-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-04
Posted: 2015-10-14
Terminated: 2017-05-18
Recalling firm: Medtronic, Inc.
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.
Product code: OUT Intracranial Aneurysm Flow Diverter
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.
Root cause tag: manufacturing process
FDA 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: [email protected]. 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 in commerce: 23 devices
Distribution: US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0120-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0120-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-14

Product code OUT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)