Z-1453-2014Class I

Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the...

Name: Z-1453-2014 Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the...
Creator: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Published: 2014-04-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-04-01 / Terminated

FDA source

Micro Therapeutics Inc, Dba Ev3 Neurovascular began a recall of Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery on 2014-04-01. FDA classified it as Class I and gives the reason as "Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1453-2014
Classification: Class I
Status: Terminated
Initiated: 2014-04-01
Posted: 2014-04-16
Terminated: 2014-10-31
Recalling firm: Medtronic, Inc.
Product: Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Product code: DQY Catheter, Percutaneous
Reason for recall: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
FDA root cause: Process change control
Action: A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate adn detach from the devices. Consumers are instructed to report any adverse reactions or quality problems experienced with the use of the product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Consumers with may also contact Covidien Customer Service at (800) 716-6700 between 7am to 7pm (central) or email at [email protected].
Quantity in commerce: 32 units total (23 units in US)
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.
Product codes and lots: PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856431 FA7730010 / 9869991 FA7737514 / 9855933 FA7742518 / 9860762 FA7732514 / 9873854 FA7737516 / 9858010 FA7745014 / 9874111 FA7735014 / 9855265 FA7740016 / 9859214 FA7745016 / 9879736 FA7735014 / 9875267 FA7740016 / 9879180 FA7747514 / 9868888

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1453-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1453-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16
Z-1454-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code DQY

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)