Z-2045-2013Class II

Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular...

Name: Z-2045-2013 Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular...
Creator: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Published: 2013-07-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-07-19 / Terminated / root cause: manufacturing process

FDA source

Micro Therapeutics Inc, Dba Ev3 Neurovascular began a recall of Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with... on 2013-07-19. FDA classified it as Class II and gives the reason as "Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing...". 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-2045-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-19
Posted: 2013-08-23
Terminated: 2013-10-17
Recalling firm: Medtronic, Inc.
Product: Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Product code: OUT Intracranial Aneurysm Flow Diverter
Reason for recall: Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Covidien sent an Customer Notification letter dated July 19, 2013, to all affected customers who received affected lots of Pipeline Embolization Device (PED). The customer notification letter informed the customers of the problems identified and the actions to be taken. Customer are instructed to reply and fax response form to Covidien Customer Service at (763) 398-7001. Customers are instructed that Customer Service will issue an RGA number for the return of the affected product back to Covidien. Customers are also instructed that upon receipt of a Returned Goods Authorization (RGA) number, to write the RGA number on the FEDEX slip and send the product back to: Covidien Attention: Product Recall 14005 13th Ave Plymouth, MN 55441 Prepaid and preaddressed FEDEX slips are enclosed for their convenience. Once Covidien receives the returned units, product replacement units will be shipped directly to customers. Local Covidien Neurovascular representative is also available to assist them in expediting the exchange of product. Customers with any questions, are instructed to call (949) 839-3700.
Quantity in commerce: 62 units
Distribution: US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.
Product codes and lots: Model/Lot Numbers: FA-71400-25 / 9747602 FA-77350-18 / 9749412 FA-77400-20 / 9759088 FA-71500-35 / 9747604 FA-77375-16 / 9744487 FA-77425-16 / 9752788 FA-77300-16 / 9757068 FA-77375-20 / 9757065 FA-77425-20 / 9744123 FA-77325-14 / 9759141 FA-77400-14 / 9757233 FA-77425-20 / 9752438 FA-77325-16 / 9753034 FA-77400-14 / 9768698 FA-77450-18 / 9753033 FA-77325-16 / 9757024 FA-77400-16 / 9743468 FA-77475-20 / 9752787 FA-77325-18 / 9759560 FA-77400-18 / 9751579 FA-77500-20 / 9750678 FA-77350-16 / 9752785 FA-77400-20 / 9755707

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2045-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2045-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-23

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)